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