Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2022 | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component ... | Certain units have the potential to exhibit infant failures whereby units either arrive non-funct... | Class II | Mako Surgical Corporation |
| Aug 5, 2022 | Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| 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 5, 2022 | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| Aug 5, 2022 | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| Aug 3, 2022 | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, COR... | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembl... | Class II | Merit Medical Systems, Inc. |
| Aug 3, 2022 | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product wa... | The packaging may not be sealed, which could compromise sterility. | Class II | Collagen Matrix Inc |
| Aug 3, 2022 | CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CO... | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembl... | Class II | Merit Medical Systems, 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 | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - D... | Potential for intraoperative screw head separation at weld location. | Class II | Integrity Implants Inc. |
| 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 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: +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 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 2, 2022 | FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm... | Sterility with new cotton source not validated | Class II | Carwild Corporation |
| Aug 1, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, nar... | Excessive ultraviolet-C radiation | Class II | MERCHSOURCE LLC |
| Aug 1, 2022 | 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| 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 | The Randox Serology I Positive Control contains the following analytes in hum... | ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckm... | Class II | Randox Laboratories Ltd. |
| Aug 1, 2022 | 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| 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 |
| 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 | MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | MicroClave Clear Neutral Connector. A bidirectional connector used as an acce... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| 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 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 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 | 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| 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 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, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| 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 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 | 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 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 | 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 | 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 | 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 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 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 | 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 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 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 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 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 | 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 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 | 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 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. |
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.