Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 2, 2022	HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022	HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Oct 31, 2022	Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734	Potential open seal pouches compromising sterility resulting in the use of a non-sterile product ...	Class II	Owens & Minor Distribution, Inc.
Oct 31, 2022	Unity Total Knee System. Used for knee prosthesis in total knee replacement	The internal packaging system for devices may have damage to the blisters potentially damaging th...	Class II	Corin Ltd
Sep 28, 2022	Pilling Wecksorb Cylindrical Sponges	Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the a...	Class II	TELEFLEX LLC
Sep 16, 2022	Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lo...	Blister package had an unsealed edge compromising sterility.	Class II	International Medical Industries, Inc.
Sep 8, 2022	Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91	The kits are being recalled due to a lack of sterility of a spare needle contained within the kit...	Class II	SunMed Holdings, LLC
Aug 16, 2022	Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
Aug 16, 2022	Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN...	Cook Medical identified that devices from the affected device lots may have a complete breach of ...	Class II	Cook Incorporated
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
Jul 22, 2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated

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.