Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Sep 1, 2022 | Recreo Hair Growth Laser Comb | The firm distributed the laser products without affixing the warning, aperture, certification, an... | Class II | OMM Imports, Inc. dba Zero Gravity |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Aug 12, 2022 | COVID Test Kit Nonsterile | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... | Class II | American Contract Systems, Inc. |
| Aug 9, 2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate ... | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels ... | Class II | Hologic, Inc |
| Aug 5, 2022 | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. in... | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal ... | Class II | Datascope Corporation |
| Aug 3, 2022 | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright ... | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... | Class II | Wright Medical Technology, Inc. |
| Aug 3, 2022 | MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wrigh... | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... | Class II | Wright Medical Technology, Inc. |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 1, 2022 | BD MaxGuard Extension Set, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-por... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Catalog Number: 6566 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Posi-Stop Injection Needle Catalog Number: 4712 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 4563 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref:... | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catal... | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Posi-Stop Injection Needle Catalog Number: 4720 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Helical Retrieval Basket Catalog Number: 4814 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 7202 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Scope Introducer Catalog Number: 4650 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Catalog Number: 6535 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 4564 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Retrieval Forceps Catalog Number: 5018 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Helical Retrieval Basket Catalog Number: 4830 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Catalog Number: 6534 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Grasping Forceps Catalog Number: 5008 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Posi-Stop Injection Needle Catalog Number: 4704 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Helical Retrieval Basket Catalog Number: 4816 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Catalog Number: 6562 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endo... | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
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.