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 |
|---|---|---|---|---|
| Mar 9, 2017 | POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually pac... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 3, 2017 | Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm),... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curi... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile It... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code:... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device t... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device t... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Jan 26, 2017 | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Ste... | Customer reports of the device handset continuing to operate after release of the activation button. | Class II | COVIDIEN MEDTRONIC |
| 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 |
| Nov 15, 2016 | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Onl... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| 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 |
| Oct 4, 2016 | Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... | Product sterility is compromised due to breach of the sterile barrier | Class II | Medtronic |
| 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 |
| Jun 6, 2016 | Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... | Class II | Covidien, LLC |
| Jun 6, 2016 | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... | 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 |
| Apr 1, 2016 | Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I... | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm | Class II | Medtronic |
| Apr 1, 2016 | Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ... | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm | Class II | Medtronic |
| 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 |
| 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 |
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.