Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 780 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 15, 2024	Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, Inc.
Nov 15, 2024	Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, Inc.
Nov 15, 2024	Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, Inc.
Oct 14, 2024	Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L...	Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut...	Class II	Defibtech, LLC
Oct 14, 2024	Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline...	Within the Irish Market, a Field Safety Notice is being issued due to a select number of authoriz...	Class II	Defibtech, LLC
Oct 14, 2024	Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ...	Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut...	Class II	Defibtech, LLC
Oct 14, 2024	Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel...	Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut...	Class II	Defibtech, LLC
Oct 4, 2024	Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Oct 4, 2024	Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push But...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Oct 4, 2024	Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk No...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Oct 4, 2024	Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Oct 4, 2024	Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-B...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Oct 4, 2024	Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm -...	There is a potential for the product to activate without manual input when plugged into a power s...	Class II	Stryker Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 160478...	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000, Product code REF 1841046	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 V, Product code REF 1841050	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Sep 19, 2024	Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083	The firm received customer reports stating that the batteries and their connectors experienced el...	Class II	Baxter Healthcare Corporation
Aug 30, 2024	IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8...	During a production process, Philips became aware of one IntelliVue power supply with a broken gr...	Class II	Philips North America
Aug 22, 2024	KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 00...	Potential installation issue that could result in a fire hazard in the event of an interaction be...	Class I	Kinova Inc
Aug 9, 2024	GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant war...	GE HealthCare has become aware that complete electrical safety testing was not conducted during m...	Class II	Wipro GE Healthcare Private Ltd.
Aug 9, 2024	GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1...	GE HealthCare has become aware that complete electrical safety testing was not conducted during m...	Class II	Wipro GE Healthcare Private Ltd.
Aug 2, 2024	Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p...	Class II	AURIS HEALTH INC
Aug 2, 2024	Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch ...	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p...	Class II	AURIS HEALTH INC
Jul 31, 2024	MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1...	Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i...	Class I	Medtronic MiniMed, Inc.
Jul 31, 2024	MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,...	Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i...	Class I	Medtronic MiniMed, Inc.
Jul 31, 2024	MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I...	Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i...	Class I	Medtronic MiniMed, Inc.
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jun 17, 2024	Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.