Browse Device Recalls
1,398 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,398 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 1,398 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
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.