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.

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DateProductReasonClassFirm
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.