Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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Date	Product	Reason	Class	Firm
Sep 8, 2021	Kit: Central Line Dres Change 20/Cs	The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.	Class II	Medical Action Industries, Inc. 306
Sep 8, 2021	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3...	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in...	Class II	Datascope Corp.
Sep 8, 2021	Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068	Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the ins...	Class II	K2M, Inc
Sep 8, 2021	Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi...	Due to a component in kit being labeled with the incorrect Expiration Date	Class II	Fujifilm Irvine Scientific, Inc.
Sep 8, 2021	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3...	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b...	Class II	Datascope Corp.
Sep 7, 2021	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	DJO, LLC
Sep 7, 2021	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	DJO, LLC
Sep 7, 2021	Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E...	Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, howe...	Class II	W L Gore & Associates, Inc.
Sep 7, 2021	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physio...	Error in the device firmware results in the inaccurate detection of device position.	Class II	NOX MEDICAL
Sep 3, 2021	ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLB...	The devices malfunction under specific operator workflows.	Class II	Welch Allyn Inc Mortara
Sep 3, 2021	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201	Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-...	Class II	Flower Orthopedics Corporation
Sep 3, 2021	cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog N...	False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas...	Class II	Roche Molecular Systems, Inc.
Sep 2, 2021	REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming...	DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming Syst...	Class I	Deroyal Industries, Inc. Lafollette
Sep 2, 2021	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali...	There is a potential for false positive results.	Class I	Abbott Molecular, Inc.
Sep 2, 2021	REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diamete...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diamete...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat...	There is a potential for false positive results.	Class I	Abbott Molecular, Inc.
Sep 2, 2021	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin...	There is a potential for false positive results.	Class I	Abbott Molecular, Inc.
Sep 2, 2021	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic...	There is a potential for false positive results.	Class I	Abbott Molecular, Inc.
Sep 2, 2021	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	Under certain conditions, there is a risk for a false negative result.	Class II	BioMerieux SA
Sep 2, 2021	REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	MOSAIQ Oncology Information System	A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved ...	Class II	Elekta, Inc.
Sep 2, 2021	Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N...	Engraving on implants may not match what is listed on the pouch labels.	Class II	Medtronic Sofamor Danek USA Inc
Sep 2, 2021	REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 2, 2021	Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N...	Engraving on implants may not match what is listed on the pouch labels.	Class II	Medtronic Sofamor Danek USA Inc
Sep 2, 2021	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat...	There is a potential for false positive results.	Class I	Abbott Molecular, Inc.
Sep 2, 2021	REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter...	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio...	Class II	W L Gore & Associates, Inc.
Sep 1, 2021	Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to...	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure	Class II	Flower Orthopedics Corporation
Sep 1, 2021	Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and c...	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure	Class II	Flower Orthopedics Corporation
Sep 1, 2021	Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can...	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure	Class II	Flower Orthopedics Corporation
Sep 1, 2021	Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and...	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure	Class II	Flower Orthopedics Corporation
Aug 31, 2021	Medtronic sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 31, 2021	Medtronic sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 31, 2021	Medtronic Sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 31, 2021	Thoraguard Chest Tube Kit, 20 Fr	An adhesive joint in the SmartValve component of the device can become compromised resulting in a...	Class II	Centese Inc.
Aug 30, 2021	OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Com...	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Ti...	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000	software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1...	Class II	Siemens Medical Solutions USA, Inc
Aug 30, 2021	SOMATOM Drive with software syngo.CT VB20 Model #10431700	software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1...	Class II	Siemens Medical Solutions USA, Inc
Aug 30, 2021	SOMATOM Confidence with software syngo.CT VB20 Model #10590100	software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1...	Class II	Siemens Medical Solutions USA, Inc
Aug 30, 2021	SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603	software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1...	Class II	Siemens Medical Solutions USA, Inc
Aug 30, 2021	OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ...	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f...	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Component...	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a....	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.	Class II	Exactech, Inc.
Aug 30, 2021	SOMATOM Force with software syngo.CT VB20 Model #10742326	software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1...	Class II	Siemens Medical Solutions USA, 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.