Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 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 675 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 23, 2015 Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm I... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Co... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066 Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Cod... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Co... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33c... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508 Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 F... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Co... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408 Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 88881... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm ... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Cod... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm ... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23c... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 F... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28c... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 23, 2015 Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr... Catheters may not meet antimicrobial specification Class II Covidien LLC
Apr 16, 2015 Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog N... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711 Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog ... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA222... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Nu... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog N... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numb... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUB... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, si... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog ... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Nu... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Mar 23, 2015 Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Feb 11, 2015 Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Techno... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Jan 12, 2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Dec 10, 2014 Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... Class I Covidien

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.