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Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

85 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 85 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 85 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 2, 2026 Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Nov 26, 2025 Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
May 15, 2025 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... Cook Medical identified that catheters supplied in the affected device lots may experience tip se... Class I Cook Incorporated
Apr 17, 2025 Tornado Embolization Microcoil, intended for embolization of selective vessel... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Oct 14, 2024 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Devices from the affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Sep 16, 2024 Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or... Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complain... Class II Cook Incorporated
May 15, 2024 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 15, 2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
Mar 1, 2024 Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Intended to be used for dilating puncture sites or catheter tracts ... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
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

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.