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 |
|---|---|---|---|---|
| Dec 19, 2014 | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Prod... | Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle ... | Class II | Angiodynamics |
| Nov 25, 2014 | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog ... | While servicing a unit at a customer site, a field engineer discovered a broken bolt from the car... | Class II | Carestream Health Inc |
| Nov 19, 2014 | VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 17, 2014 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... | Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 6, 2014 | CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direc... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPA... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro di... | Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. | Class II | Ortho-Clinical Diagnostics |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- CO... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- C... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- CO... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COM... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, D... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Nov 6, 2014 | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPA... | Philips Healthcare made changes to the design of the connection between multifunction electrodes ... | Class I | ConMed Corporation |
| Oct 30, 2014 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images th... | Reduced mammographic image quality when attempting to print true size multi-format images | Class II | Carestream Health, Inc. |
| Oct 27, 2014 | Turbo Troponin I For in vitro diagnostic use for the quantitative measurem... | Class II | Siemens Healthcare Diagnostics, Inc. | |
| Oct 20, 2014 | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I... | A typographical error regarding the expiration date was identified in the control module instruct... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2014 | ADVIA Centaur XP Immunoassay System (including refurbished) Professional u... | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2014 | ADVIA Centaur (including refurbished) Professional use in a laboratory for... | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 19, 2014 | IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 1... | Customer complaints were received for positive bias reported on the controls used on the IMMULITE... | Class II | Siemens Healthcare Diagnostics |
| Sep 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LU... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier ... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 20, 2014 | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671,... | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using V... | Class II | Ortho-Clinical Diagnostics |
| Aug 19, 2014 | ADVIA Centaur Immunoassay System (including refurbished units), This syst... | The firm has identified an issue with patient demographic information sent to the LIS from the AD... | Class II | Siemens Healthcare Diagnostics |
| Aug 19, 2014 | ADVIA Centaur XP Immunoassay System (including refurbished units), This s... | The firm has identified an issue with patient demographic information sent to the LIS from the AD... | Class II | Siemens Healthcare Diagnostics |
| Aug 13, 2014 | ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (S... | The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... | Class II | Siemens Healthcare Diagnostics |
| Aug 13, 2014 | ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers... | The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... | Class II | Siemens Healthcare Diagnostics |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... | The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin... | Class II | Siemens Healthcare Diagnostics |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 5, 2014 | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL... | The firm became aware of a potential problem that was initiated by a customer complaint. After c... | Class II | Curbell Medical, Inc. |
| Jul 15, 2014 | VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and... | Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Cali... | Class II | Ortho-Clinical Diagnostics |
| Jul 9, 2014 | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7... | An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collim... | Class II | Carestream Health, Inc. |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
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.