Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 12, 2019 | VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTU... | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... | Class II | Ethicon, Inc. |
| Mar 12, 2019 | PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... | Class II | Ethicon, Inc. |
| Mar 8, 2019 | Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right,... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 5, 2019 | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled ... | Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events invo... | Class II | Fenwal Inc |
| Feb 27, 2019 | Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF ... | The device label incorrectly states that the device is sterile. This product is an externally app... | Class III | Teleflex Medical |
| Feb 27, 2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numb... | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA... | Class III | Cypress Medical Products LLC |
| Feb 27, 2019 | MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with... | Administration sets leaked at the filter. | Class II | Zevex Incorporated (dba MOOG Medical Devices Gr... |
| Feb 27, 2019 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF... | The device label incorrectly states that the device is sterile. This product is an externally app... | Class III | Teleflex Medical |
| Feb 22, 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ... | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc... | Class III | GE Healthcare, LLC |
| Feb 19, 2019 | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 19, 2019 | smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 15, 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed wit... | Class II | COVIDIEN LLC |
| Feb 11, 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes in... | Packaged with an incorrect size inner cannula. | Class II | Smiths Medical ASD Inc. |
| Feb 8, 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... | The integrity of the sterile grid packaging is potentially compromised. | Class II | Riverpoint Medical, LLC |
| Feb 5, 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Inner blister pack label is incorrect and does not match the correct external box label. | Class III | SPINEART SA |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Jan 31, 2019 | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile,... | The product was mislabeled with an incorrect expiration date. | Class II | RHONDIUM LIMITED |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 28, 2019 | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOn... | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Speci... | Class III | LivaNova USA 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.