Browse Device Recalls
690 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 690 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 690 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2016 | Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 8... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 4... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Feb 23, 2016 | Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneo... | Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" P... | Class II | Covidien Medical Products (Shanghai) Manufactur... |
| Jan 22, 2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap ... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap ... | 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 PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ 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 CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are u... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap... | 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 UM 16FR SILV TMP CSD Item Code: P4P16XTSD 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 PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 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 SIL FLY Item Code: P4P14SD P400 Castile soa... | 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 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD 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 PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap ... | 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 KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap ... | 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 ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH ... | 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 PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD ... | 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 MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap ... | 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 SIL FLY Item Code: P4P16SD Castile soap ... | 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 UL FOLY CSD Item Code: P4P18ULD Castil... | 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 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile so... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile s... | 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 PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Cast... | 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 TMP SNS CSD Item Code: P4P16TSD 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 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK 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 EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile s... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap t... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castil... | 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 PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD 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 PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CS... | 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 PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap ... | 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 SIL COUDE CATH SECURE Item Code: P4P16CSD... | 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 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 |
| Jan 15, 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| 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 |
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.