Medical device recalls — page 7

1,617 recent medical device recalls in our current data. Showing 1,201–1,400, newest first.

FDA Class I · Medical device · June 10, 2026

Atlan A350XL recall — Draeger, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Company / brand: Draeger recalls

Affected product: Atlan A350XL recall status

Official ID Z-2208-2026 · Official record ↗

FDA Class I · Medical device · June 10, 2026

Atlan A350 recall — Draeger, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Company / brand: Draeger recalls

Affected product: Atlan A350 recall status

Official ID Z-2207-2026 · Official record ↗

FDA Class II · Medical device · June 10, 2026

ARTIS Icono biplane recall — Siemens Medical Solutions USA, Inc

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-f…

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS Icono biplane recall status

Official ID Z-2206-2026 · Official record ↗

FDA Class II · Medical device · June 10, 2026

ARTIS pheno recall — Siemens Medical Solutions USA, Inc

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-f…

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS pheno recall status

Official ID Z-2205-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Medline medical convenience kit labeled as EYE TRAY-LF recall — Medline Industries, LP

Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and b…

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kit labeled as EYE TRAY-LF recall status

Official ID Z-2260-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Allura system recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an H…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Allura system recall status

Official ID Z-2259-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Azurion system recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an H…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Azurion system recall status

Official ID Z-2258-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare ApexPro v6 recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare ApexPro v6 recall status

Official ID Z-2247-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall status

Official ID Z-2246-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall status

Official ID Z-2245-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER recall status

Official ID Z-2244-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare APEXPRO v5 recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare APEXPRO v5 recall status

Official ID Z-2243-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL recall — GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result…

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL recall status

Official ID Z-2242-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation recall — Medtronic Neuromodulation

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

Company / brand: Medtronic Neuromodulation recalls

Affected product: Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation recall status

Official ID Z-2241-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation recall — Medtronic Neuromodulation

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

Company / brand: Medtronic Neuromodulation recalls

Affected product: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation recall status

Official ID Z-2240-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

HydroMARK Breast Biopsy Site Marker recall — Devicor Medical Products Inc

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

Company / brand: Devicor Medical Products recalls

Affected product: HydroMARK Breast Biopsy Site Marker recall status

Official ID Z-2239-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in cert…

Company / brand: Abiomed recalls

Affected product: Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall status

Official ID Z-2238-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2237-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2236-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2235-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2234-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2233-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2232-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…

Company / brand: Medline Industries recalls

Affected product: Medline kits containing Huons Co recall status

Official ID Z-2231-2026 · Official record ↗

FDA Class II · Medical device · June 3, 2026

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers recall — O&M HALYARD INC

Nitrile Exam Glove failed to meet specifications chemical permeation performance.

Company / brand: O&M HALYARD recalls

Affected product: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers recall status

Official ID Z-2230-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Automated Impella Controller (AIC) recall — Abiomed, Inc.

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented th…

Company / brand: Abiomed recalls

Affected product: Automated Impella Controller (AIC) recall status

Official ID Z-2211-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

Company / brand: Bolton Medical recalls

Affected product: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall status

Official ID Z-2160-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Integris-Allura system recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leaka…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Integris-Allura system recall status

Official ID Z-2229-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Allura system recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leaka…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Allura system recall status

Official ID Z-2228-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Azurion system recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leaka…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Azurion system recall status

Official ID Z-2227-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF recall — C.R. Bard Inc

Due to stain present on the surface of affected foley catheters.

Company / brand: C.R. Bard recalls

Affected product: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF recall status

Official ID Z-2226-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Philips Azurion systems not configured with an optional auxiliary pan handle recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the c…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Philips Azurion systems not configured with an optional auxiliary pan handle recall status

Official ID Z-2225-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2222-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2221-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall status

Official ID Z-2220-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall status

Official ID Z-2219-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2218-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2217-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2216-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR recall status

Official ID Z-2215-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR recall — Medtronic Perfusion Systems

Certain lots of product have the potential for a sterile barrier breach.

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR recall status

Official ID Z-2214-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

OneLIF Interbody Cage (REF/Description) recall — Novapproach Spine, LLC

Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, …

Company / brand: Novapproach Spine recalls

Affected product: OneLIF Interbody Cage (REF/Description) recall status

Official ID Z-2213-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Oncology Kit w/60" (152 cm) Appx 2 recall — ICU Medical, Inc.

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy …

Company / brand: ICU Medical recalls

Affected product: Oncology Kit w/60" (152 cm) Appx 2 recall status

Official ID Z-2210-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Tangent Endoscopy recall — TANGENT ENDOSCOPY, LLC

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

Company / brand: TANGENT ENDOSCOPY recalls

Affected product: Tangent Endoscopy recall status

Official ID Z-2209-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Swan-Ganz Pacing Catheter recall — Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl…

Company / brand: Becton recalls

Affected product: Swan-Ganz Pacing Catheter recall status

Official ID Z-2204-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Swan-Ganz Jr Catheter recall — Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl…

Company / brand: Becton recalls

Affected product: Swan-Ganz Jr Catheter recall status

Official ID Z-2203-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Swan-Ganz Catheter recall — Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl…

Company / brand: Becton recalls

Affected product: Swan-Ganz Catheter recall status

Official ID Z-2202-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application recall — Medtronic Neuromodulation

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earl…

Company / brand: Medtronic Neuromodulation recalls

Affected product: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application recall status

Official ID Z-2201-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

LVIS Intraluminal Support Device recall — MICROVENTION INC.

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to …

Company / brand: MICROVENTION recalls

Affected product: LVIS Intraluminal Support Device recall status

Official ID Z-2200-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Medtronic Marinr Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Medtronic Marinr Steerable recall status

Official ID Z-2199-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable BDB recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable BDB recall status

Official ID Z-2198-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2197-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2196-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2195-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2194-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2193-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2192-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2191-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2190-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2189-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2188-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2187-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Daig Livewire Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: Daig Livewire Steerable recall status

Official ID Z-2186-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

CS Uni-Directional w Auto ID recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: CS Uni-Directional w Auto ID recall status

Official ID Z-2185-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

CS Uni-Directional w Auto ID recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: CS Uni-Directional w Auto ID recall status

Official ID Z-2184-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BW Webster Duo-Decapolar recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BW Webster Duo-Decapolar recall status

Official ID Z-2183-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD EP XT Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD EP XT Steerable recall status

Official ID Z-2182-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD EP XT Decapolar Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD EP XT Decapolar Steerable recall status

Official ID Z-2181-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic XT Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic XT Steerable recall status

Official ID Z-2180-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic XT Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic XT Steerable recall status

Official ID Z-2179-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic XT Deca Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic XT Deca Steerable recall status

Official ID Z-2178-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic Tip Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic Tip Steerable recall status

Official ID Z-2177-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic Tip Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic Tip Steerable recall status

Official ID Z-2176-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic Tip Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic Tip Steerable recall status

Official ID Z-2175-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

BARD Dynamic Deca Steerable recall — Stryker Sustainability Solutions

Incomplete seals on sterile product

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD Dynamic Deca Steerable recall status

Official ID Z-2174-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Codman CerebroFlo EVD Catheter with Endexo Technology recall — Integra LifeSciences Corp. (NeuroSciences)

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Company / brand: Integra LifeSciences (NeuroSciences) recalls

Affected product: Codman CerebroFlo EVD Catheter with Endexo Technology recall status

Official ID Z-2173-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Edwards EVOQUE tricuspid delivery system REF recall — Edwards Lifesciences, LLC

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Company / brand: Edwards Lifesciences recalls

Affected product: Edwards EVOQUE tricuspid delivery system REF recall status

Official ID Z-2172-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

ZYMUTEST HIA IgG recall — Aniara Diagnostica LLC

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Company / brand: Aniara Diagnostica recalls

Affected product: ZYMUTEST HIA IgG recall status

Official ID Z-2171-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Philips Azurion recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces …

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Affected product: Philips Azurion recall status

Official ID Z-2170-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

QuickVue Dipstick Strep A Test recall — Quidel Corporation

Product has the potential for false positive results

Company / brand: Quidel recalls

Affected product: QuickVue Dipstick Strep A Test recall status

Official ID Z-2169-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

3DIMENSIONS MAMMOGRAPHY SYSTEM recall — Hologic, Inc

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Company / brand: Hologic recalls

Affected product: 3DIMENSIONS MAMMOGRAPHY SYSTEM recall status

Official ID Z-2168-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS recall — Hologic, Inc

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Company / brand: Hologic recalls

Affected product: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS recall status

Official ID Z-2167-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code recall — Stryker Corporation

Due to nonconforming products being inadvertently distributed.

Company / brand: Stryker recalls

Affected product: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code recall status

Official ID Z-2166-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — Dexcom, Inc.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app…

Company / brand: Dexcom recalls

Affected product: Brand Name recall status

Official ID Z-2165-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — Dexcom, Inc.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app…

Company / brand: Dexcom recalls

Affected product: Brand Name recall status

Official ID Z-2164-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — Dexcom, Inc.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app…

Company / brand: Dexcom recalls

Affected product: Brand Name recall status

Official ID Z-2163-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Diowave Laser System recall — Technological Medical Advancements LLC

Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthri…

Company / brand: Technological Medical Advancements recalls

Affected product: Diowave Laser System recall status

Official ID Z-2162-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

LUCAS 2 Model Number recall — Jolife AB

Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justif…

Company / brand: Jolife AB recalls

Affected product: LUCAS 2 Model Number recall status

Official ID Z-2161-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLC

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and …

Company / brand: ARROW INTERNATIONAL recalls

Affected product: NextStep Antegrade Chronic Hemodialysis Catheter recall status

Official ID Z-2159-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Cannon II Plus Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLC

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and …

Company / brand: ARROW INTERNATIONAL recalls

Affected product: Cannon II Plus Hemodialysis Catheter recall status

Official ID Z-2158-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLC

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and …

Company / brand: ARROW INTERNATIONAL recalls

Affected product: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall status

Official ID Z-2157-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Arrow Edge Hemodialysis Catheterization Product recall — ARROW INTERNATIONAL, LLC

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and …

Company / brand: ARROW INTERNATIONAL recalls

Affected product: Arrow Edge Hemodialysis Catheterization Product recall status

Official ID Z-2156-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution Apex Select recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution Apex Select recall status

Official ID Z-2155-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution Apex recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution Apex recall status

Official ID Z-2154-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution CT ES recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution CT ES recall status

Official ID Z-2153-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution Apex Plus recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution Apex Plus recall status

Official ID Z-2152-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution Apex Elite recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution Apex Elite recall status

Official ID Z-2151-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution CT recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution CT recall status

Official ID Z-2150-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Revolution Ascend recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with …

Company / brand: GE Medical Systems recalls

Affected product: Revolution Ascend recall status

Official ID Z-2149-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Medline medical convenience kits recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits recall status

Official ID Z-2148-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Medline medical convenience kits recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits recall status

Official ID Z-2147-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Medline medical convenience kits recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits recall status

Official ID Z-2146-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

1 recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: 1 recall status

Official ID Z-2145-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

1 recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: 1 recall status

Official ID Z-2144-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Medline medical convenience kits recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Medline medical convenience kits recall status

Official ID Z-2143-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Namic Preceptor Manifold recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Namic Preceptor Manifold recall status

Official ID Z-2142-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Namic Preceptor Manifold recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Namic Preceptor Manifold recall status

Official ID Z-2141-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Namic Angiographic Manifold recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Namic Angiographic Manifold recall status

Official ID Z-2140-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Namic Angiographic Manifold recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Namic Angiographic Manifold recall status

Official ID Z-2139-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Namic Angiographic Manifold recall — Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Company / brand: Medline Industries recalls

Affected product: Namic Angiographic Manifold recall status

Official ID Z-2138-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — DJO, LLC

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Company / brand: DJO recalls

Affected product: Brand Name recall status

Official ID Z-2137-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — DJO, LLC

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Company / brand: DJO recalls

Affected product: Brand Name recall status

Official ID Z-2136-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — DJO, LLC

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Company / brand: DJO recalls

Affected product: Brand Name recall status

Official ID Z-2135-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

Brand Name recall — DJO, LLC

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Company / brand: DJO recalls

Affected product: Brand Name recall status

Official ID Z-2134-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

On-X Mitral Heart Valve with Conform-X Sewing Ring recall — On-X Life Technologies, Inc.

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Company / brand: On-X Life Technologies recalls

Affected product: On-X Mitral Heart Valve with Conform-X Sewing Ring recall status

Official ID Z-2133-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes wit recall — Windstone Medical Packaging, Inc.

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose …

Company / brand: Windstone Medical Packaging recalls

Affected product: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes wit recall status

Official ID Z-2066-2026 · Official record ↗

FDA Class I · Medical device · May 20, 2026

Rolls of label stock used with the Omnicell i recall — Omnicell, Inc.

Potential for mislabeled syringe produced by the i.v.STATION device.

Company / brand: Omnicell recalls

Affected product: Rolls of label stock used with the Omnicell i recall status

Official ID Z-2047-2026 · Official record ↗