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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.