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