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 |
|---|---|---|---|---|
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ... | Sterility may be compromised | Class II | Covidien LLC |
| Jul 31, 2015 | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product ... | Infant Heel warmers may break during activation resulting in spillage of the contents on patients... | Class II | Covidien LLC |
| Jul 31, 2015 | Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Produc... | Infant Heel warmers may break during activation resulting in spillage of the contents on patients... | Class II | Covidien LLC |
| Jul 16, 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For c... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of func... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Apr 29, 2015 | Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glov... | Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufa... | Class II | Centurion Medical Products Corporation |
| Apr 28, 2015 | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vasc... | Possible sterility breach of the outer packaging (pouch) material which may compromise the outsid... | Class II | Covidien LLC |
| Apr 27, 2015 | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ... | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or... | Class II | DeRoyal Industries Inc |
| 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 |
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.