Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 27, 2015 | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real ... | Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 24, 2015 | EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLi... | Potential for the device cannula to overthrow past the intended length. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Apr 24, 2015 | D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with... | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe... | Class II | GE Healthcare |
| 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 HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item C... | 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 Kit 14.5 Fr x 28cm Item Code: 8888245064 | 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 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 SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Cod... | Catheters may not meet antimicrobial specification | Class II | Covidien LLC |
| 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 SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item C... | 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 w/VenaTrac Stylet 14.5 Fr x 23cm Item Cod... | 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: 8888145066C | Catheters may not meet antimicrobial specification | Class II | Covidien LLC |
| Apr 23, 2015 | Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458 | 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 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 Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm... | 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 33cm ... | 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 33cm... | 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 Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 88881... | 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 28cm Item C... | Catheters may not meet antimicrobial specification | Class II | Covidien LLC |
| Apr 23, 2015 | Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063 | 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 23cm ... | Catheters may not meet antimicrobial specification | Class II | Covidien LLC |
| Apr 23, 2015 | Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 88881... | 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 33cm... | 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 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 Sport Pack w/VenaTrac Stylet 14.5 F... | 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 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 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 Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm I... | 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 19cm... | 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 19cm Item C... | 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 19c... | Catheters may not meet antimicrobial specification | Class II | Covidien LLC |
| Apr 23, 2015 | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... | A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in th... | Class II | Philips Medical Systems, Inc. |
| 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 |
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.