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 16, 2017 | Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individuall... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and st... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| 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 |
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.