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.

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Date	Product	Reason	Class	Firm
Sep 2, 2020	Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper A...	Product potentially being packaged without a taper adapter or baseplate. The package should conta...	Class II	Biomet, Inc.
Sep 1, 2020	ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T...	There have been reports of the suction catheter coming apart from the device assembly during use.	Class II	Medline Industries Inc
Sep 1, 2020	AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodia...	Incorrectly crimped connectors were installed on the main protective earth conductor on these mac...	Class II	Fresenius Medical Care Holdings, Inc.
Aug 31, 2020	Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, ...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 31, 2020	Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light ...	Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.	Class II	Ultradent Products, Inc.
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001	Potential for Fluid leaks within the instruments, creating an electrical short inside the power s...	Class II	Roche Diagnostics Operations, Inc.
Aug 31, 2020	Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to b...	The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associate...	Class II	Olympus Corporation of the Americas
Aug 31, 2020	31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbe...	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Nu...	Potential for Fluid leaks within the instruments, creating an electrical short inside the power s...	Class II	Roche Diagnostics Operations, Inc.
Aug 31, 2020	76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Ol...	The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the d...	Class II	Olympus Corporation of the Americas
Aug 31, 2020	30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu...	Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.	Class II	Encore Medical, LP
Aug 31, 2020	BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cr...	Brainlab Ultrasound Navigation Software does not support the modification of the probe's image wi...	Class II	Brainlab AG
Aug 31, 2020	26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 28, 2020	Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to...	Label has the incorrect size for the tracheotomy tube.	Class II	Smiths Medical ASD Inc.
Aug 28, 2020	VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -...	Blood collection tubes experienced an issue with separation and clotting	Class II	Greiner Bio-One North America, Inc.
Aug 28, 2020	Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t...	Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potentia...	Class II	Siemens Healthcare Diagnostics Inc
Aug 27, 2020	Tina-quant Complement C4 ver.2, Catalog 05991994190	Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for...	Class III	Roche Diagnostics Operations, Inc.
Aug 27, 2020	Albumin Gen.2, Catalog 05166861190	Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for...	Class III	Roche Diagnostics Operations, Inc.
Aug 26, 2020	BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF...	Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjuga...	Class II	Beckman Coulter Inc.
Aug 26, 2020	EVOLVE STEM 8.5MM Model # 496S085	Lack of sterility assurance	Class II	Wright Medical Technology Inc
Aug 26, 2020	Pacific Xtreme (PTCA Balloon Dilation Catheter)	Labeling discrepancy for the Rated Burst Pressure (RBP) value.	Class II	ev3 Inc.
Aug 25, 2020	Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI...	Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IF...	Class II	Siemens Healthcare Diagnostics, Inc
Aug 25, 2020	Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Ca...	Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete...	Class II	Terumo Cardiovascular Systems Corporation
Aug 25, 2020	Change Healthcare Radiology Solutions 14.0	Software defect which may potentially result in one or more images missing in a study	Class II	CHANGE HEALTHCARE CANADA COMPANY
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Aug 25, 2020	Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Nu...	Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete...	Class II	Terumo Cardiovascular Systems Corporation
Aug 25, 2020	Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigat...	The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery ...	Class II	Genicon, 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.