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 23, 2017 | Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-... | Sterility compromised due to breach in sterile barrier | Class II | Covidien LLC |
| Jan 23, 2017 | Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe... | Sterility compromised due to breach in sterile barrier | Class II | Covidien LLC |
| Dec 16, 2016 | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellc... | Labeling error: The label indicates the product is latex free, but the headband component include... | Class II | Covidien LLC |
| Oct 14, 2016 | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... | Sterility of the outer surface of the container compromised due to packaging defect. | Class II | Covidien LLC |
| Sep 29, 2016 | Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Produ... | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | Class II | Covidien LLC |
| Sep 29, 2016 | Covidien Devon Light Glove packaged in sterile surgical kits Reference: 3114... | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | Class II | Covidien LLC |
| Sep 29, 2016 | Professional Hospital Supply, Inc Custom Packaging containing the Devon Light... | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | Class II | Covidien LLC |
| Apr 15, 2016 | Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Apr 15, 2016 | Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 c... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 6... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Sof... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| 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 |
| 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 |
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.