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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DateProductReasonClassFirm
May 10, 2018 CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and c... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire P... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 5F DL BIOFLO PICC, Catalog Number 60M180592 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL XPP, Catalog Number 60M019881 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Nu... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M132324 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 5F DL BIOFLO PASV, Catalog Number 60M141006 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 9, 2018 VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diag... There is a potential for imprecise results when using the slides. Increase in imprecision when u... Class II Ortho-Clinical Diagnostics
May 8, 2018 Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightS... In certain eyepiece configurations the laser shutter may not close completely, permitting reflect... Class II Zeiss, Carl Inc
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 8, 2018 Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DI... The device is equipped with a dial that has an inaccurate flow rate indicator. Class II Dynarex Corporation
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 5, 2018 VITROS Sodium Slides, Catalog # 837 9034 Potential for positively biased results Class II Ortho-Clinical Diagnostics
Apr 30, 2018 PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 25, 2018 Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. ... When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadv... Class II Intersurgical Inc
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Mar 27, 2018 ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... Class II Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic t... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
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.

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.