Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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Date	Product	Reason	Class	Firm
Aug 10, 2022	Verify SixCess Challenge Pack. Used to confirm that critical parameters of s...	Product contains incorrect chemical indicators in packaging.	Class III	Steris Corporation Hopkins Facility
Aug 10, 2022	Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700	Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and...	Class II	Siemens Medical Solutions USA, Inc
Aug 10, 2022	Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F),...	Bleed monitoring system device design error, causing the device to not power on and complete the ...	Class II	Saranas, Inc.
Aug 9, 2022	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Ca...	Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, o...	Class I	Jiangsu Well Biotech Co.,Ltd.
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 9, 2022	Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product C...	Firm noted an increase in customer reports of leaks.	Class I	Baxter Healthcare Corporation
Aug 9, 2022	Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/...	Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner a...	Class II	Technomed Europe
Aug 9, 2022	Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440	The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve...	Class II	Boston Scientific Corporation
Aug 9, 2022	Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B	Products were distributed in the United States without FDA authorization or clearance.	Class I	DEWEI MEDICAL EQUIPMENT CO LTD
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 8, 2022	CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; B...	Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.	Class II	GS Biomark LLC
Aug 8, 2022	PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, ...	Product may contain the incorrect material which could impact treatment.	Class II	Ethicon, Inc.
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	Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter	Certain lots containing undersized dilator.	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	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	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	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	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 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 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 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	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	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 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	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	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	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	The product is a handheld ultraviolet-C germicidal wand and contains two, nar...	Excessive ultraviolet-C radiation	Class II	MERCHSOURCE LLC
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	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	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; 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	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
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.
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.

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.