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 |
|---|---|---|---|---|
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H7496004... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 602... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 6006... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 6015... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 600709... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 8, 2015 | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete ... | Units device head descended unexpectedly | Class II | Carestream Health, Inc. |
| Jan 8, 2015 | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to pro... | Units device head descended unexpectedly | Class II | Carestream Health, Inc. |
| Dec 29, 2014 | VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the fo... | In combination with the Batch Programming option (only) for programming samples, the hand-held ba... | Class II | Ortho-Clinical Diagnostics |
| 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 |
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.