Fresh Recalls

Medical device recalls — page 4

1,617 recent medical device recalls in our current data. Showing 601–800, newest first.

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2853-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2852-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2851-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2850-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2849-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2848-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2847-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2846-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2845-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2844-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2843-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2842-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Brand Name recall — Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…

Company / brand: Pride Mobility Products recalls

Affected product: Brand Name recall status

Official ID Z-2841-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Company / brand: Boston Scientific recalls

Affected product: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN recall status

Official ID Z-2840-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Company / brand: Boston Scientific recalls

Affected product: Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN recall status

Official ID Z-2839-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Company / brand: Boston Scientific recalls

Affected product: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN recall status

Official ID Z-2838-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Kingfisher Compact Individual First Aid Kit recall — INTEGRATED MEDCRAFT LLC

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Company / brand: INTEGRATED MEDCRAFT recalls

Affected product: Kingfisher Compact Individual First Aid Kit recall status

Official ID Z-2837-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

FORWARD Oral Airway Kit (OPA Sizes 5 recall — INTEGRATED MEDCRAFT LLC

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Company / brand: INTEGRATED MEDCRAFT recalls

Affected product: FORWARD Oral Airway Kit (OPA Sizes 5 recall status

Official ID Z-2836-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Charger for the Therabody Theragun recall — Therabody, Inc

Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the prod…

Company / brand: Therabody recalls

Affected product: Charger for the Therabody Theragun recall status

Official ID Z-2835-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

REMISOL Advance with Software Version 2 recall — Beckman Coulter Biomedical GmbH

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting …

Company / brand: Beckman Coulter Biomedical recalls

Affected product: REMISOL Advance with Software Version 2 recall status

Official ID Z-2834-2026 · Official record ↗

FDA Class I · Medical device · August 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…

Company / brand: AVID Medical recalls

Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall status

Official ID Z-2798-2026 · Official record ↗

FDA Class I · Medical device · August 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…

Company / brand: AVID Medical recalls

Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall status

Official ID Z-2797-2026 · Official record ↗

FDA Class I · Medical device · August 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…

Company / brand: AVID Medical recalls

Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall status

Official ID Z-2796-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 150mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 150mm recall status

Official ID Z-2833-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 120mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 120mm recall status

Official ID Z-2832-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm recall status

Official ID Z-2831-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 60mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 60mm recall status

Official ID Z-2830-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall status

Official ID Z-2829-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm recall status

Official ID Z-2828-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Stryker Hoffmann II Connecting Rod Micro 3 x 30mm recall — Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Company / brand: Stryker recalls

Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 30mm recall status

Official ID Z-2827-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: Brand Name recall status

Official ID Z-2826-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: Brand Name recall status

Official ID Z-2825-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: Brand Name recall status

Official ID Z-2824-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: Brand Name recall status

Official ID Z-2823-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: Brand Name recall status

Official ID Z-2822-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

GEM Premier 5000 with IQM2 Model/Catalog Number recall — Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Company / brand: Instrumentation Laboratory recalls

Affected product: GEM Premier 5000 with IQM2 Model/Catalog Number recall status

Official ID Z-2821-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

OsteoBallast recall — IsoTis OrthoBiologics, Inc.

Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc…

Company / brand: IsoTis OrthoBiologics recalls

Affected product: OsteoBallast recall status

Official ID Z-2820-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2819-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2818-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2817-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2816-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2815-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2814-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2813-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2812-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA 3D Arterial Cannula 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA 3D Arterial Cannula 22FR recall status

Official ID Z-2811-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA 3D Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA 3D Arterial Cannula DIL TIP 22FR recall status

Official ID Z-2810-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall status

Official ID Z-2809-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall status

Official ID Z-2808-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall status

Official ID Z-2807-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall — Medtronic Perfusion Systems

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall status

Official ID Z-2806-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

M5 Corpus Power Wheelchair REF recall — Permobil Inc

This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, a…

Company / brand: Permobil recalls

Affected product: M5 Corpus Power Wheelchair REF recall status

Official ID Z-2805-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm recall — Argon Medical Devices, Inc

Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking a…

Company / brand: Argon Medical Devices recalls

Affected product: L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm recall status

Official ID Z-2804-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

L-Cath PICC S/L Peripherally Inserted Central Catheter recall — Argon Medical Devices, Inc

Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking a…

Company / brand: Argon Medical Devices recalls

Affected product: L-Cath PICC S/L Peripherally Inserted Central Catheter recall status

Official ID Z-2803-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2802-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2801-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2800-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall status

Official ID Z-2799-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF recall — Permobil Inc

This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the use…

Company / brand: Permobil recalls

Affected product: Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF recall status

Official ID Z-2795-2026 · Official record ↗

FDA Class I · Medical device · August 5, 2026

Pack Angiography NCMC 3/Cs BANNER recall — Medical Action Industries, Inc. 306

Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood…

Company / brand: Medical Action Industries recalls

Affected product: Pack Angiography NCMC 3/Cs BANNER recall status

Official ID Z-2792-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Power Over Fiber Base Module recall — Terex Utilities

Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for…

Company / brand: Terex Utilities recalls

Affected product: Power Over Fiber Base Module recall status

Official ID Z-2745-2026 · Official record ↗

FDA Class I · Medical device · August 5, 2026

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous recall — ResMed Ltd.

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

Company / brand: ResMed recalls

Affected product: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous recall status

Official ID Z-2735-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity recall — PHILIPS MEDICAL SYSTEMS

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…

Company / brand: PHILIPS MEDICAL SYSTEMS recalls

Affected product: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity recall status

Official ID Z-2652-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

IQon Spectral CT IQon Spectral CT Upgrades recall — PHILIPS MEDICAL SYSTEMS

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…

Company / brand: PHILIPS MEDICAL SYSTEMS recalls

Affected product: IQon Spectral CT IQon Spectral CT Upgrades recall status

Official ID Z-2651-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B recall — PHILIPS MEDICAL SYSTEMS

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…

Company / brand: PHILIPS MEDICAL SYSTEMS recalls

Affected product: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B recall status

Official ID Z-2650-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Flexible Hystero-Fiberscope Kits REF recall — Karl Storz Endoscopy

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could …

Company / brand: Karl Storz Endoscopy recalls

Affected product: Flexible Hystero-Fiberscope Kits REF recall status

Official ID Z-2794-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

SafeOp Patient Interface recall — Alphatec Spine, Inc.

Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as sys…

Company / brand: Alphatec Spine recalls

Affected product: SafeOp Patient Interface recall status

Official ID Z-2793-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline medical convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits labeled as recall status

Official ID Z-2791-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline medical convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits labeled as recall status

Official ID Z-2790-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline medical convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits labeled as recall status

Official ID Z-2789-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline medical convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits labeled as recall status

Official ID Z-2788-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2787-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2786-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2785-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2784-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2783-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2782-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2781-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2780-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall status

Official ID Z-2779-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

MiniMed Go App recall — Medtronic MiniMed, Inc.

For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be t…

Company / brand: Medtronic MiniMed recalls

Affected product: MiniMed Go App recall status

Official ID Z-2778-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Emano Flow with software version v2 recall — Emano Metrics, Inc.

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validat…

Company / brand: Emano Metrics recalls

Affected product: Emano Flow with software version v2 recall status

Official ID Z-2777-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Olympus High Flow Insufflation Unit - UHI-4 recall — Olympus Corporation of the Americas

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus High Flow Insufflation Unit - UHI-4 recall status

Official ID Z-2776-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

SnapshotGLO Wound Imaging Device recall — KENT IMAGING, INC.

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shippin…

Company / brand: KENT IMAGING recalls

Affected product: SnapshotGLO Wound Imaging Device recall status

Official ID Z-2775-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Pipeline Flex Embolization Device with Shield Technology recall — Micro Therapeutics, Inc.

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Company / brand: Micro Therapeutics recalls

Affected product: Pipeline Flex Embolization Device with Shield Technology recall status

Official ID Z-2774-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Pipeline Flex Embolization Device with Shield Technology recall — Micro Therapeutics, Inc.

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Company / brand: Micro Therapeutics recalls

Affected product: Pipeline Flex Embolization Device with Shield Technology recall status

Official ID Z-2773-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Halyard STANDARD LINE INSERTION PACK recall — AVID Medical, Inc.

Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

Company / brand: AVID Medical recalls

Affected product: Halyard STANDARD LINE INSERTION PACK recall status

Official ID Z-2772-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform recall — Boston Scientific Corporation

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu…

Company / brand: Boston Scientific recalls

Affected product: Boston Scientific TheraSphere 360 Y-90 Management Platform recall status

Official ID Z-2771-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Penumbra System RED 68 Reperfusion Catheter REF recall — Penumbra, Inc.

Due to manufacturing issues, reperfusion catheters may fractures

Company / brand: Penumbra recalls

Affected product: Penumbra System RED 68 Reperfusion Catheter REF recall status

Official ID Z-2770-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Brand Name recall — Prismatik Dentalcraft, Inc.

Due to device not having FDA Clearance

Company / brand: Prismatik Dentalcraft recalls

Affected product: Brand Name recall status

Official ID Z-2769-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Ventriculostomy Kit recall — Medtronic Neurosurgery

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices …

Company / brand: Medtronic Neurosurgery recalls

Affected product: Ventriculostomy Kit recall status

Official ID Z-2768-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

3mensio Workstation (Vascular Fenestrated) software recall — PIE Medical Imaging B.V.

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d…

Company / brand: PIE Medical Imaging B.V recalls

Affected product: 3mensio Workstation (Vascular Fenestrated) software recall status

Official ID Z-2767-2026 · Official record ↗

FDA Class I · Medical device · July 29, 2026

MEDLINE medical procedure convenience kit labeled as recall — Medline Industries, LP

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…

Company / brand: Medline Industries recalls

Affected product: MEDLINE medical procedure convenience kit labeled as recall status

Official ID Z-2765-2026 · Official record ↗

FDA Class I · Medical device · July 29, 2026

MEDLINE medical procedure convenience kit labeled as recall — Medline Industries, LP

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…

Company / brand: Medline Industries recalls

Affected product: MEDLINE medical procedure convenience kit labeled as recall status

Official ID Z-2764-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Halyard EYE PACK recall — AVID Medical, Inc.

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

Company / brand: AVID Medical recalls

Affected product: Halyard EYE PACK recall status

Official ID Z-2763-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

SeaSpine Polyaxial Head REF Number recall — SEASPINE ORTHOPEDICS CORPORATION

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Company / brand: SEASPINE ORTHOPEDICS recalls

Affected product: SeaSpine Polyaxial Head REF Number recall status

Official ID Z-2762-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Olympus 4K UHD LCD Monitor recall — Olympus Corporation of the Americas

Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus 4K UHD LCD Monitor recall status

Official ID Z-2761-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Power F2 Powered Fastening System recall — Ferno-Washington Inc

Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may b…

Company / brand: Ferno-Washington recalls

Affected product: Power F2 Powered Fastening System recall status

Official ID Z-2760-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Hotline Fluid Warming Set recall — ICU Medical Inc.

ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t…

Company / brand: ICU Medical recalls

Affected product: Hotline Fluid Warming Set recall status

Official ID Z-2759-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall — Paragon 28, Inc.

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Company / brand: Paragon 28 recalls

Affected product: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall status

Official ID Z-2758-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Company / brand: Boston Scientific recalls

Affected product: FARADRIVE STEERABLE SHEATH CLEAR OUS recall status

Official ID Z-2757-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Company / brand: Boston Scientific recalls

Affected product: FARADRIVE STEERABLE SHEATH (CLEAR) - US recall status

Official ID Z-2756-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Company / brand: Boston Scientific recalls

Affected product: FARADRIVE STEERABLE SHEATH CLEAR recall status

Official ID Z-2755-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE Steerable Sheath Clear IDE recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Company / brand: Boston Scientific recalls

Affected product: FARADRIVE Steerable Sheath Clear IDE recall status

Official ID Z-2754-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Ablation Generator EU recall — Boston Scientific Corporation

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Company / brand: Boston Scientific recalls

Affected product: FARASTAR Ablation Generator EU recall status

Official ID Z-2753-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR PFA Generator recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Company / brand: Boston Scientific recalls

Affected product: FARASTAR PFA Generator recall status

Official ID Z-2752-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Pulsed Field Ablation Generator recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Company / brand: Boston Scientific recalls

Affected product: FARASTAR Pulsed Field Ablation Generator recall status

Official ID Z-2751-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Ablation Generator EU recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Company / brand: Boston Scientific recalls

Affected product: FARASTAR Ablation Generator EU recall status

Official ID Z-2750-2026 · Official record ↗

FDA Class I · Medical device · July 29, 2026

MEDLINE convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…

Company / brand: Medline Industries recalls

Affected product: MEDLINE convenience kits labeled as recall status

Official ID Z-2749-2026 · Official record ↗

FDA Class I · Medical device · July 29, 2026

MEDLINE convenience kits labeled as recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…

Company / brand: Medline Industries recalls

Affected product: MEDLINE convenience kits labeled as recall status

Official ID Z-2748-2026 · Official record ↗

FDA Class I · Medical device · July 29, 2026

MEDLINE ANTERIOR HIP recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…

Company / brand: Medline Industries recalls

Affected product: MEDLINE ANTERIOR HIP recall status

Official ID Z-2747-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

The intended use is to be paired with a weapon for aiming purposes recall — Wilcox Industries Corp.

Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be retu…

Company / brand: Wilcox Industries recalls

Affected product: The intended use is to be paired with a weapon for aiming purposes recall status

Official ID Z-2675-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ST AIA-Pack Testosterone recall — Tosoh Bioscience Inc

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated…

Company / brand: Tosoh Bioscience recalls

Affected product: ST AIA-Pack Testosterone recall status

Official ID Z-2746-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Photera 600 3-D recall — Daavlin Distributing Company

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Company / brand: Daavlin Distributing Company recalls

Affected product: Photera 600 3-D recall status

Official ID Z-2744-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Photera 600 recall — Daavlin Distributing Company

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Company / brand: Daavlin Distributing Company recalls

Affected product: Photera 600 recall status

Official ID Z-2743-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Photera 400 recall — Daavlin Distributing Company

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Company / brand: Daavlin Distributing Company recalls

Affected product: Photera 400 recall status

Official ID Z-2742-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 recall — Maquet Cardiovascular, LLC

Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878…

Company / brand: Maquet Cardiovascular recalls

Affected product: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 recall status

Official ID Z-2741-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Brand Name recall — 3B Medical, Inc.

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Company / brand: 3B Medical recalls

Affected product: Brand Name recall status

Official ID Z-2740-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Medtronic Bio-Medicus Adult Cannula Kit recall — Medtronic Perfusion Systems

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic Bio-Medicus Adult Cannula Kit recall status

Official ID Z-2739-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Medtronic DLP One-Piece Pediatric Arterial Cannula recall — Medtronic Perfusion Systems

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP One-Piece Pediatric Arterial Cannula recall status

Official ID Z-2738-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ616 recall — Medline Industries, LP

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…

Company / brand: Medline Industries recalls

Affected product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ616 recall status

Official ID Z-2737-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 recall — Medline Industries, LP

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…

Company / brand: Medline Industries recalls

Affected product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 recall status

Official ID Z-2736-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Papablic Replacement Brush Heads recall — Papablic Inc

Potential for brush heads to break.

Company / brand: Papablic recalls

Affected product: Papablic Replacement Brush Heads recall status

Official ID Z-2734-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Papablic Replacement Brush Heads recall — Papablic Inc

Potential for brush heads to break.

Company / brand: Papablic recalls

Affected product: Papablic Replacement Brush Heads recall status

Official ID Z-2733-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Orthofix MINIRAIL recall — Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Company / brand: Orthofix U.S recalls

Affected product: Orthofix MINIRAIL recall status

Official ID Z-2732-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF recall — Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Company / brand: Orthofix U.S recalls

Affected product: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF recall status

Official ID Z-2731-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Orthofix MINIRAIL recall — Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Company / brand: Orthofix U.S recalls

Affected product: Orthofix MINIRAIL recall status

Official ID Z-2730-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Orthofix MINIRAIL recall — Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Company / brand: Orthofix U.S recalls

Affected product: Orthofix MINIRAIL recall status

Official ID Z-2729-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Optima XR240amx recall — GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…

Company / brand: GE Medical Systems recalls

Affected product: Optima XR240amx recall status

Official ID Z-2728-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Optima XR220amx recall — GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…

Company / brand: GE Medical Systems recalls

Affected product: Optima XR220amx recall status

Official ID Z-2727-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Optima XR200amx recall — GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…

Company / brand: GE Medical Systems recalls

Affected product: Optima XR200amx recall status

Official ID Z-2726-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Rapid Refill Continuous Injection System recall — Boston Scientific Corporation

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loo…

Company / brand: Boston Scientific recalls

Affected product: Rapid Refill Continuous Injection System recall status

Official ID Z-2725-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Solo Precision IV Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Company / brand: ICU Medical recalls

Affected product: ICU Medical Plum Solo Precision IV Pump recall status

Official ID Z-2724-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Duo Infusion Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Company / brand: ICU Medical recalls

Affected product: ICU Medical Plum Duo Infusion Pump recall status

Official ID Z-2723-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

da Vinci SP Instrument Arm Drape recall — Intuitive Surgical, Inc.

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a secti…

Company / brand: Intuitive Surgical recalls

Affected product: da Vinci SP Instrument Arm Drape recall status

Official ID Z-2722-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Glass Body for 194 Ellik Evacuator recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Glass Body for 194 Ellik Evacuator recall status

Official ID Z-2721-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Ellik Evacuator Includes Glass Body recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Ellik Evacuator Includes Glass Body recall status

Official ID Z-2720-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 50cc with Adaptor recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Toomey Evacuator 50cc with Adaptor recall status

Official ID Z-2719-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 30cc with Adaptor recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Toomey Evacuator 30cc with Adaptor recall status

Official ID Z-2718-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Bone Marrow Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: Bone Marrow Tray recall status

Official ID Z-2709-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Arterial Line Kit 20ga x 6 recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: Arterial Line Kit 20ga x 6 recall status

Official ID Z-2708-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

T-Lok Bone Marrow Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: T-Lok Bone Marrow Tray recall status

Official ID Z-2707-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

General Biospy Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: General Biospy Tray recall status

Official ID Z-2706-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

One-Piece Introducer Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: One-Piece Introducer Tray recall status

Official ID Z-2705-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Affected product: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall status

Official ID Z-2704-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Intro Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Intro Kit recall status

Official ID Z-2693-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Insertion Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Insertion Kit recall status

Official ID Z-2692-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Set recall status

Official ID Z-2691-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Smart Assist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Smart Assist Set recall status

Official ID Z-2690-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Set recall status

Official ID Z-2689-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella 5 recall status

Official ID Z-2688-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella 5 recall status

Official ID Z-2687-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2686-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2685-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Introducer Kit 23 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Introducer Kit 23 Fr recall status

Official ID Z-2684-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2683-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Set recall status

Official ID Z-2682-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella RP Flex with SmartAssist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella RP Flex with SmartAssist Set recall status

Official ID Z-2681-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Affected product: Abiomed REF recall status

Official ID Z-2680-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Affected product: Abiomed REF recall status

Official ID Z-2679-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Affected product: Abiomed REF recall status

Official ID Z-2678-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — CMR SURGICAL LIMITED

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Company / brand: CMR SURGICAL recalls

Affected product: Brand Name recall status

Official ID Z-2717-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

TMINI Femur Tracking Array REF 109003 UDI-DI code recall — Think Surgical, Inc.

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

Company / brand: Think Surgical recalls

Affected product: TMINI Femur Tracking Array REF 109003 UDI-DI code recall status

Official ID Z-2716-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

VITEK 2 AST-N447 TEST KIT Product reference 424620 recall — Biomerieux Inc

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Company / brand: Biomerieux recalls

Affected product: VITEK 2 AST-N447 TEST KIT Product reference 424620 recall status

Official ID Z-2715-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

OmniTract Surgical Retractor System recall — Integra LifeSciences Corp. (NeuroSciences)

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 …

Company / brand: Integra LifeSciences (NeuroSciences) recalls

Affected product: OmniTract Surgical Retractor System recall status

Official ID Z-2714-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

GSP Neonatal GALT Kit recall — WALLAC OY

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

Company / brand: WALLAC OY recalls

Affected product: GSP Neonatal GALT Kit recall status

Official ID Z-2713-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Affected product: Brand Name recall status

Official ID Z-2712-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Affected product: Brand Name recall status

Official ID Z-2711-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Affected product: Brand Name recall status

Official ID Z-2710-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patien…

Company / brand: Siemens Healthcare Diagnostics recalls

Affected product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall status

Official ID Z-2703-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

5008X Blood Tubing Set recall — Fresenius Medical Care Holdings, Inc.

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Company / brand: Fresenius Medical Care Holdings recalls

Affected product: 5008X Blood Tubing Set recall status

Official ID Z-2702-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Encore Medical, LP

Due to packaging discrepancy with incorrect product size mixed up.

Company / brand: Encore Medical recalls

Affected product: Brand Name recall status

Official ID Z-2701-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Encore Medical, LP

Due to packaging discrepancy with incorrect product size mixed up.

Company / brand: Encore Medical recalls

Affected product: Brand Name recall status

Official ID Z-2700-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

KL Owen Custom Orthodontic Solution recall — Klowen Braces

A product error defect may cause incorrect bracket placement.

Company / brand: Klowen Braces recalls

Affected product: KL Owen Custom Orthodontic Solution recall status

Official ID Z-2699-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

MiniMed 780G Insulin Pump recall — Medtronic MiniMed, Inc.

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error me…

Company / brand: Medtronic MiniMed recalls

Affected product: MiniMed 780G Insulin Pump recall status

Official ID Z-2698-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2697-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2696-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2695-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Intracept Access Instruments recall — Boston Scientific Neuromodulation Corporation

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to…

Company / brand: Boston Scientific Neuromodulation recalls

Affected product: Intracept Access Instruments recall status

Official ID Z-2694-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Aquacel Ag Surgical SP REF recall — ConvaTec, Inc

Surgical dressing manufactured out of specification (greater thickness).

Company / brand: ConvaTec recalls

Affected product: Aquacel Ag Surgical SP REF recall status

Official ID Z-2677-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Olympus Single Use Distal Cover recall — Olympus Corporation of the Americas

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Single Use Distal Cover recall status

Official ID Z-2676-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…

Company / brand: Zimmer Surgical recalls

Affected product: Brand Name recall status

Official ID Z-2674-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…

Company / brand: Zimmer Surgical recalls

Affected product: Brand Name recall status

Official ID Z-2673-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region recall — W L Gore & Associates, Inc.

Due to catheter separation

Company / brand: W L Gore & Associates recalls

Affected product: GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region recall status

Official ID Z-2672-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Radius VSM Disposable NIBP Cuff recall — Masimo Corporation

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…

Company / brand: Masimo recalls

Affected product: Radius VSM Disposable NIBP Cuff recall status

Official ID Z-2671-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Radius VSM ECG pre-connected Set recall — Masimo Corporation

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…

Company / brand: Masimo recalls

Affected product: Radius VSM ECG pre-connected Set recall status

Official ID Z-2670-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Solar GI System (Water Perfusion) recall — Laborie Medical Technologies Corp

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the h…

Company / brand: Laborie Medical Technologies recalls

Affected product: Solar GI System (Water Perfusion) recall status

Official ID Z-2669-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall status

Official ID Z-2668-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code recall status

Official ID Z-2667-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code recall status

Official ID Z-2666-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code recall status

Official ID Z-2665-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code recall status

Official ID Z-2664-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code recall status

Official ID Z-2663-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code recall status

Official ID Z-2662-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen recall status

Official ID Z-2661-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Co recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Co recall status

Official ID Z-2660-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC recall status

Official ID Z-2659-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code recall status

Official ID Z-2658-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code recall status

Official ID Z-2657-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code recall status

Official ID Z-2656-2026 · Official record ↗

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Sources last checked October 22, 2026 at 12:00 PM UTC.