Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 26, 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1... | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Molnlycke Health Care, Inc |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product U... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" includin... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recal... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 20, 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes | Class III | GETINGE US SALES LLC |
| Mar 15, 2019 | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabele... | The form received three complaints related to the user obtaining a result that fell below the tar... | Class II | Response Biomedical Corp. |
| Mar 15, 2019 | Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re... | There is an error in the chromomap included in the labeling for the product. | Class III | Cytocell Ltd. |
| Mar 13, 2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | Procedure kits include devices from the affected lots distributed OUS only: ... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 12, 2019 | VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN... | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... | Class II | Ethicon, Inc. |
| Mar 12, 2019 | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... | Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... | Class II | Beaver Visitec |
| 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 |
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.