Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 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 1,361 FDA device recalls in NY.

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Date	Product	Reason	Class	Firm
Jan 2, 2018	IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge	The concentrations for biotin listed in the non-interfering substances section of the instruction...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ /IMMULITE ¿ 1000 CEA	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	ADVIA Centaur¿ HBc IgM	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge	The concentrations for biotin listed in the non-interfering substances section of the instruction...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	ADVIA Centaur¿ DHEA-SO4	The concentrations for biotin listed in the non-interfering substances section of the instruction...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018	IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)	Concentrations for the level of biotin that does not interfere is not currently listed in the ins...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2017	ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (10...	In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2017	ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbe...	In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 4, 2017	Ultra Renew	Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation	Class II	Accord Media, LLC
Dec 4, 2017	Truth Renew Plus	Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation	Class II	Accord Media, LLC
Dec 4, 2017	Truth Renew	Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation	Class II	Accord Media, LLC
Dec 4, 2017	Ultra Renew Plus	Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation	Class II	Accord Media, LLC
Nov 3, 2017	ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Nov 3, 2017	NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us...	Contact lenses lack sterility assurance.	Class II	Alden Optical
Oct 17, 2017	Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL...	Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 17, 2017	BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 a...	The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (c...	Class II	Siemens Healthcare Diagnostics
Oct 6, 2017	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI...	Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu...	Class II	Baxter Healthcare Corporation
Sep 22, 2017	VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri...	Class II	Ortho-Clinical Diagnostics
Sep 22, 2017	Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individu...	The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c...	Class II	Circulatory Technology Inc
Sep 22, 2017	VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri...	Class II	Ortho-Clinical Diagnostics
Sep 22, 2017	VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri...	Class II	Ortho-Clinical Diagnostics
Sep 22, 2017	**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary ...	The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c...	Class II	Circulatory Technology Inc
Sep 22, 2017	VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri...	Class II	Ortho-Clinical Diagnostics
Sep 22, 2017	VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri...	Class II	Ortho-Clinical Diagnostics
Sep 22, 2017	Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c...	Product was placed into distribution prior to completion of all required post sterilization relea...	Class II	Angiodynamics, Inc.
Sep 1, 2017	Respire Pink+ Hard Oral Sleep Apnea Device	Potential for device breakage during use	Class II	Respire Medical
Sep 1, 2017	Respire Pink+ Hard/Soft Oral Sleep Apnea Device	Potential for device breakage during use	Class II	Respire Medical
Sep 1, 2017	Respire Pink H/S Oral Sleep Apnea Device	Potential for device breakage during use	Class II	Respire Medical
Sep 1, 2017	Respire Pink H/S Oral Sleep Apnea Device	Potential for device breakage during use	Class II	Respire Medical
Sep 1, 2017	Respire Pink Series EF+ Oral Sleep Apnea Device.	Potential for device breakage during use	Class II	Respire Medical
Sep 1, 2017	Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com...	The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la...	Class III	CooperVision Inc.
Aug 31, 2017	LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrica...	A shipment of LCSU 4 suction units and canisters attempted importation into the United States but...	Class II	Laerdal Medical Corporation

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.