Browse Device Recalls

1,382 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,382 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 1,382 FDA device recalls in NY.

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DateProductReasonClassFirm
Feb 23, 2018 MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ... Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... Class II ConMed Corporation
Feb 23, 2018 MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog N... Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... Class II ConMed Corporation
Feb 23, 2018 MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ... Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... Class II ConMed Corporation
Feb 23, 2018 MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, ... Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... Class II ConMed Corporation
Feb 23, 2018 MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Co... Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... Class II ConMed Corporation
Feb 21, 2018 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 15, 2018 Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT101... The sterility of the device cannot be assured. There is a potential for an increased risk of infe... Class II Transonic Systems Inc
Jan 18, 2018 Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in F... NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in a... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Jan 11, 2018 VITROS Immunodiagnostic Products TSH Reagent Pack VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signa... Class III Clinical Diagnostic Systems
Jan 2, 2018 ADVIA Centaur¿ Folate (FOL) 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 TG 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¿ Cardiac Troponin I (CTNI) 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 TG 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 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 Dimension¿ Thyroid Stimulating Hormone (TSHL) 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 3g Allergy specific IgE Universal Kit 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 Vitamin B12 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¿ Cyclosporine 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 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

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.