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
Aug 5, 2021	Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 5, 2021	Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stab...	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 5, 2021	Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLoc...	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 5, 2021	Mammary Nodules Localization	Sterility assurance may be compromised.	Class II	M.D.L. S.r.l.
Aug 5, 2021	Soft Tissue Biopsy Needles	Sterility assurance may be compromised.	Class II	M.D.L. S.r.l.
Aug 5, 2021	Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" St...	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 5, 2021	Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 5, 2021	Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine ...	There is potential for packaging defects that may impact the sterile barrier.	Class II	C.R. Bard Inc
Aug 4, 2021	Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun...	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Mac Medical Supply Co Inc
Aug 4, 2021	smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X...	The incorrect device is contained in the package.	Class II	Smiths Medical ASD Inc.
Aug 4, 2021	Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 Spectru...	Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient sam...	Class II	Abbott Molecular, Inc.
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Aug 4, 2021	cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catal...	Customers have reported an increased number of false positive SARS-CoV-2 results.	Class II	Roche Molecular Systems, Inc.
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Aug 3, 2021	Verigene EP Amplification Reagent Kit Test	There is potential for false positive results.	Class II	Luminex Corporation
Aug 3, 2021	AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - ...	AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideli...	Class II	Fresenius Medical Care Holdings, Inc.
Aug 3, 2021	Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number:...	Packaging seal defect may allow a breach of the package sterile barrier and result in patient inf...	Class II	Olympus Corporation of the Americas
Aug 2, 2021	Flow sensors kept as stand-alone user replaceable spare parts for the GEHC an...	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t...	Class II	GE Healthcare, LLC
Aug 2, 2021	BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	uMI 550 System - Product Usage: intended to be operated by qualified healthca...	The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Aug 2, 2021	BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSi...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/ad...	Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).	Class II	Magnolia Medical Technologies, Inc.
Aug 2, 2021	BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access D...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF:...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	Flow sensors that may be installed in the following GEHC anesthesia machines:...	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t...	Class II	GE Healthcare, LLC
Aug 2, 2021	BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD Sma...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified...	The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Aug 2, 2021	BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing Smart...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Aug 2, 2021	BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAM...	Needle-free connector valves, either standalone or attached to extension sets, may have issues in...	Class II	CAREFUSION
Jul 30, 2021	Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for u...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Arjo Disposable Repositioning Sling, Model AHD001	Sling loop straps on device pose a trip hazard.	Class II	Getinge Dominican Republic SA
Jul 30, 2021	Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicate...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection ...	A thin wall condition between the inner cannulation and the flutes of the drill which potentially...	Class II	Paragon 28, Inc.
Jul 30, 2021	Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use ...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for...	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re...	Class II	Philips North America Llc
Jul 30, 2021	BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375	Product may not perform as specified in IFU.	Class II	Leica Microsystems, Inc.
Jul 29, 2021	HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144	One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook mode...	Class II	Mizuho OSI
Jul 29, 2021	ECHELON Oval MRI System	There was no label on the pad packaging or notification in the user manual that the table pads c...	Class II	Hitachi Healthcare Americas Corporation

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.