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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.