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 22, 2021	QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleedin...	Lack of Packaging seal integrity may result in a sterile barrier breach.	Class II	Z-Medica, LLC
Sep 22, 2021	VIDAS LH, REF 30406-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	ROSA One 3.1 Brain application The device is intended for the spatial posi...	The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le...	Class I	MEDTECH SAS
Sep 22, 2021	Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861	Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 22, 2021	VIDAS PRG Progesterone, REF 30409-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	VIDAS Lyme IgG II (LYM), REF 417401	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	VIDAS Estradiol II, REF 30431-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	VIDAS TOXO IgG Avidity (TXGA), REF 30222-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	VIDAS SARS-COV-2 IgM, Ref 423833-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866	Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 22, 2021	VIDAS FSH, REF 30407-01	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 22, 2021	VIDAS RUB IgG (RBG), REF 30226	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro...	Class II	bioMerieux, Inc.
Sep 21, 2021	EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232	Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unr...	Class II	Philips Ultrasound Inc
Sep 21, 2021	Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card...	A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run...	Class I	Datascope Corp.
Sep 21, 2021	The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of th...	Incorrect expiration date on its package labeling (shipper box and inner carton label).	Class II	Intuitive Surgical, Inc.
Sep 21, 2021	ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoline...	Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in ...	Class II	Olympus Corporation of the Americas
Sep 20, 2021	Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ...	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r...	Class I	Arrow International Inc
Sep 20, 2021	Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ...	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r...	Class I	Arrow International Inc
Sep 20, 2021	Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543	The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent ...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 20, 2021	Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ...	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r...	Class I	Arrow International Inc
Sep 20, 2021	Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ...	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r...	Class I	Arrow International Inc
Sep 20, 2021	Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151	The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reag...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 20, 2021	6.5MMX165MM CANNULATED SCREW	The product label incorrectly indicated that the screws are fully threaded, but the screws contai...	Class II	Smith & Nephew, Inc.
Sep 17, 2021	BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pa...	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reag...	Class II	Bio-Rad Laboratories, Inc.
Sep 17, 2021	Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta...	There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ...	Class II	Elekta, Inc.
Sep 17, 2021	BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL T...	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reag...	Class II	Bio-Rad Laboratories, Inc.
Sep 14, 2021	Elekta Monaco - Product Usage: used to make treatment plans for patients with...	Contour changes can be saved on an unintended image set. In addition, these contour edits do not ...	Class II	Elekta Inc
Sep 14, 2021	The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr...	Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist &...	Class II	Bayer Medical Care, Inc.
Sep 13, 2021	ARCH Leg Positioning System	Due to the holes not being bored to the specific diameter, the locking pins are unable to engage ...	Class II	Innovative Orthopedic Technologies, LLC
Sep 13, 2021	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion...	There was a label mix-up between two model numbers resulting in the incorrect guidewire being con...	Class II	Medtronic Perfusion Systems
Sep 10, 2021	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (I...	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Co...	Class II	Ortho Clinical Diagnostics Inc
Sep 10, 2021	Standard IUD Insertion Kit	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	Endometrial Biopsy Kit	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	Tenaculum, Plastic	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ...	Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti...	Class II	Draeger Medical, Inc.
Sep 10, 2021	FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different br...	The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to a...	Class II	Inpeco S.A.
Sep 10, 2021	Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)	The belt may fail at lower loads than the labeled 600lbs.	Class II	Kinsman Enterprises Inc
Sep 10, 2021	IUD Insertion Kit	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for t...	Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti...	Class II	Draeger Medical, Inc.
Sep 10, 2021	IUD Insertion Pack	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	Foundation Kit	Firm unable to confirm that the tenaculum devices were produced in accordance with required desig...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021	FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 0...	During a regular requalification review, affected flexible intubation video endoscopes did not ac...	Class II	Karl Storz Endoscopy
Sep 9, 2021	TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B...	If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or ...	Class II	RAYSEARCH LABORATORIES AB
Sep 9, 2021	GENOSYL DS (Delivery System) console, for use as a vasodilator.	Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery ...	Class I	Vero Biotech, LLC
Sep 9, 2021	ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacem...	Packaging may include screws that are not intended to be used with the 5mm augments, may cause de...	Class II	DePuy Orthopaedics, Inc.
Sep 9, 2021	C315-HIS Delivery Catheter	Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Sep 8, 2021	BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Cathe...	There is a breach in the product packaging that renders the product non-sterile.	Class II	Becton Dickinson Infusion Therapy Systems Inc.
Sep 8, 2021	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7...	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in...	Class II	Datascope Corp.
Sep 8, 2021	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7...	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b...	Class II	Datascope Corp.
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.

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.