Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

Date	Product	Reason	Class	Firm
Dec 30, 2020	ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th...	The Quality Control (QC) card has a label error for the standard deviation (SD) values for one ou...	Class II	Beckman Coulter Inc.
Dec 30, 2020	Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product ...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 30, 2020	Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 30, 2020	Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 30, 2020	Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: i...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 30, 2020	Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 30, 2020	Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c...	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis...	Class II	Baxter Healthcare Corporation
Dec 29, 2020	REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile	Missing Instruction For Use insert.	Class II	Allergan PLC
Dec 28, 2020	Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixatio...	Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.	Class II	New Standard Device Inc
Dec 28, 2020	FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 m...	Potential for the battery to lose its ability to be recharged.	Class II	Baxter Healthcare Corporation
Dec 28, 2020	Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic ...	A failure can occur if the user attempts to remove the device by partially snipping the edge and ...	Class II	Mar-Med Co
Dec 24, 2020	PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra...	Patient tabletop moved out to the home position during scan initialization, may cause operator/by...	Class II	Philips North America
Dec 24, 2020	Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5...	Control panel arm assembly could have missing or loose screws where undue force, pressure or weig...	Class II	Philips Ultrasound Inc
Dec 23, 2020	2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 1432985...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482	The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i...	Class II	Becton Dickinson & Company
Dec 23, 2020	Pro Series Fertility Device (SKU 644042788139)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Deluxe At Home Artificial Insemination Kit (SKU 636391205832)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 13...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, ...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, S...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended ...	The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and r...	Class II	Draegar Medical Systems, Inc.
Dec 23, 2020	Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205...	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205...	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pre...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Premium At Home Pro Series Insemination Kit (SKU 644042787927)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection ...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 23350000...	The instruments may become cold welded together when the drill is inserted through the Soft Tissu...	Class II	Biomet, Inc.
Dec 23, 2020	Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood conveni...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 22, 2020	Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-...	FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo...	Class III	Fujifilm Medical Systems U.S.A., Inc.
Dec 22, 2020	The EOSedge system may acquire two simultaneous orthogonal planar images for ...	Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been...	Class II	EOS Imaging
Dec 22, 2020	Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement ...	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep...	Class II	Abbott Point Of Care Inc.
Dec 22, 2020	Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2...	Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a...	Class II	Cytocell Ltd.
Dec 22, 2020	Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of ...	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected rep...	Class II	Abbott Point Of Care Inc.
Dec 21, 2020	Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Need...	There were customer reports of separation between the tubing and Male Luer Lock Adaptor.	Class II	Baxter Healthcare Corporation
Dec 21, 2020	Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use...	Shipping box may contain wrong model.	Class II	Smiths Medical ASD Inc.
Dec 21, 2020	SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for ...	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi...	Class II	OMNIlife science Inc.
Dec 21, 2020	PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No....	Medical device non-conformance to electrical safety standard (IEC 60601-1).	Class II	Nihon Kohden America Inc
Dec 21, 2020	SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for ...	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi...	Class II	OMNIlife science 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.