Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 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 709 FDA device recalls in CT.

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DateProductReasonClassFirm
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
Apr 13, 2015 McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expo... Small sized specula were incorrectly packaged in printed bags for the medium sized speculum Class II CooperSurgical, Inc.
Mar 20, 2015 Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in... The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may n... Class II CooperSurgical, Inc.
Mar 9, 2015 WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; L... Internal gas line may malfunction causing the line to burst under pressure. Class II CooperSurgical, Inc.
Feb 9, 2015 CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 Incorrect size printed on the Milex Pessary Kit packaging label Class II CooperSurgical, Inc.
Feb 4, 2015 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Ar... Measurement values in the EMR may not accurately reflect the actual measurement value on the Syna... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 4, 2015 Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascu... Under certain circumstances the patient Demographics in a report exported into the EMR may not m... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 3, 2015 Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-10... User Manual lacks a description for handling some errors even though the system can be recovered... Class II Fujifilm Medical Systems U.S.A., Inc.
Jan 26, 2015 NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Bran... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, 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.