Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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Date	Product	Reason	Class	Firm
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case	Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. B...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case	Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC ...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	FEMORAL ARTERY PACK-LF. Sterile Procedural Tray	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	LOCAL PACK. Sterile Procedural Tray.	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. ...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOT...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	OttLite Rechargeable UVC Disinfecting Wand	Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exp...	Class II	Ottlite TEchnologies, Inc.
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 C...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS C...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022	Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATIO...	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 16, 2022	B125M Patient Monitor, REF 6160000-005-XXXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105M Patient Monitor, REF 6160000-003	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product C...	knot tensile strengths were observed to be significantly below the minimum knot tensile, will res...	Class II	Ethicon, Inc.
Nov 16, 2022	B125P Patient Monitor (with E-module slot option), REF 6160000-002	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B125M Patient Monitor, REF 6160000-004-XXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	Programmable Diagnostic Computer	The firm will be performing a software update to address a software error which affects the liste...	Class II	Siemens Medical Solutions USA, Inc
Nov 15, 2022	ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive	ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d...	Class II	ConvaTec, Inc
Nov 14, 2022	Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000...	The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging...	Class II	Insulet Corporation
Nov 14, 2022	iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE	Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ...	Class II	Conformis, Inc.
Nov 11, 2022	Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U...	The instrument was found to be installed without plunger assemblies in the clamp bar for an Ampli...	Class II	Abbott Molecular, Inc.
Nov 11, 2022	Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (Intern...	Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury ...	Class II	Stryker Medical Division of Stryker Corporation
Nov 10, 2022	Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging ...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ...	Potential that insert will be unable to disengage from the vertebral body replacement device/implant	Class II	NuVasive Inc
Nov 10, 2022	Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imagin...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obs...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K0...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 9, 2022	API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	API 20 E 25 STRIPS, CATALOG 20100	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux Inc
Nov 9, 2022	VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	Class II	Biomerieux 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.