Browse Device Recalls
334 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 334 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 334 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 22, 2016 | Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile ... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CS... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Casti... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile so... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castil... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 21, 2016 | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Con... | 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were pa... | Class II | Covidien LLC |
| Jan 21, 2016 | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Con... | 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were pa... | Class II | Covidien LLC |
| Oct 14, 2015 | Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Styl... | Incorrectly packaged with a 90 degree bend at the distal tip | Class II | Covidien LLC |
| Oct 14, 2015 | Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Styl... | Incorrectly packaged with a 90 degree bend at the distal tip | Class II | Covidien LLC |
| Oct 14, 2015 | Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft a... | Incorrectly packaged with a 90 degree bend at the distal tip | Class II | Covidien LLC |
| Oct 14, 2015 | Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 ... | Incorrectly packaged with a 90 degree bend at the distal tip | Class II | Covidien LLC |
| Oct 14, 2015 | Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm)... | Incorrectly packaged with a 90 degree bend at the distal tip | Class II | Covidien LLC |
| Aug 19, 2015 | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:2... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 19, 2015 | Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Prec... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 19, 2015 | MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsteril... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with I... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... | 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 Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Strai... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Cur... | Sterility may be compromised | Class II | Covidien LLC |
| 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 |
| 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 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 |
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.