Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 23, 2016 | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 ... | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... | Class II | Synthes (USA) Products LLC |
| May 23, 2016 | TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 T... | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... | Class II | Synthes (USA) Products LLC |
| May 23, 2016 | TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Tit... | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... | Class II | Synthes (USA) Products LLC |
| May 20, 2016 | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N | Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP becau... | Class II | SSC- Surgical Specialties Corporation |
| May 20, 2016 | K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture... | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made o... | Class II | Integra LifeSciences Corp. |
| May 20, 2016 | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | Product did not meet specifications for Zinc Acetate (OOS). | Class II | Amerx Health Care Corp. |
| May 20, 2016 | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Mer... | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. | Class II | Merz North America, Inc. |
| May 19, 2016 | Toshiba Ultimax DREX-ULT80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MS... | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. | Class II | Devicor Medical Products Inc |
| May 19, 2016 | Conical portio adapter (acorn) small & large are used for examination and dia... | The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that parti... | Class II | Richard Wolf Medical Instruments Corp. |
| May 19, 2016 | Toshiba Kalare DREX-KL80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08... | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 18, 2016 | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Uniqu... | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be gene... | Class II | Ortho-Clinical Diagnostics |
| May 18, 2016 | Monaco RTP System Product Usage: The Monaco system is used to make treatm... | When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is sele... | Class II | Elekta, Inc. |
| May 18, 2016 | Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Bi... | A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... | Class II | Conmed Corporation |
| May 18, 2016 | Proteus 235 and Proteus ONE proton therapy systems | Recall is being initiated to address on-site software installations not being performed consisten... | Class II | Ion Beam Applications S.A. |
| May 18, 2016 | Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtche... | A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... | Class II | Conmed Corporation |
| May 18, 2016 | Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable... | A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... | Class II | Conmed Corporation |
| May 18, 2016 | Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10'... | A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... | Class II | Conmed Corporation |
| May 18, 2016 | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 ... | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needl... | Class II | US Endoscopy Group Inc |
| May 18, 2016 | Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.0... | A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... | Class II | Conmed Corporation |
| May 17, 2016 | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... | Kit labeled with the incorrect expiration date. | Class III | Roche Molecular Systems, Inc. |
| May 17, 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF Rasp | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF Rasp | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF Trial | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro... | Due to the lack of updated thermal components, these instruments may be more susceptible to the i... | Class II | Beckman Coulter Inc. |
| May 17, 2016 | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder ... | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from... | Class II | Zimmer Gmbh |
| May 17, 2016 | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF Trial | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | TCA Board, 16542A A continuous ventilator intended to mechanically control o... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing N... | Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the I... | Class II | CSL Behring GmbH |
| May 17, 2016 | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 16, 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enG... | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... | Class III | Ortho-Clinical Diagnostics |
| May 16, 2016 | Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients... | Product had torn/loose seal around the mouthpiece. | Class II | FSC Laboratories, Inc |
| May 16, 2016 | Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrie... | First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valv... | Class II | Lifeline First Aid LLC |
| May 16, 2016 | 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC. | Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barr... | Class II | Lifeline First Aid LLC |
| May 13, 2016 | Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-in... | The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnoco... | Class II | Innovision A/S |
| May 13, 2016 | Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number:... | Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a pot... | Class II | Medtronic Sofamor Danek Usa, Inc - Dallas Distr... |
| May 13, 2016 | MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... | It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... | Class II | Datascope Corporation |
| May 12, 2016 | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular ... | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... | Class II | Baxter Healthcare Corp |
| May 12, 2016 | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr... | A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea... | Class II | CareFusion 303, 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.