Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Oct 4, 2013	VITROS Chemistry Products COCM Reagent	Inaccurate quality control results.	Class II	Ortho-Clinical Diagnostics
Oct 3, 2013	Invivo Corporation Expression IP5 Information Portal Product Usage: T...	Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expres...	Class II	Invivo Corporation
Oct 3, 2013	Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surg...	Complaints were received for intraoperative reamer head breakages which can allow for unretrieved...	Class II	Synthes USA HQ, Inc.
Oct 3, 2013	Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be...	During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as S...	Class II	Synthes USA HQ, Inc.
Oct 3, 2013	Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti...	A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical B...	Class II	Synthes USA HQ, Inc.
Oct 3, 2013	STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod...	Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ...	Class III	Advanced Sterilization Products
Oct 3, 2013	Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ...	Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentrati...	Class III	Lin-Zhi International Inc
Oct 3, 2013	ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo...	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut...	Class III	Biomet 3i, LLC
Oct 2, 2013	MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for ...	Manufactured with an incorrect factory set unit of measure.	Class II	Nipro Diagnostics, Inc.
Oct 2, 2013	The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low powe...	The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. ...	Class II	EKOS Corporation
Oct 2, 2013	Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94...	A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu...	Class II	Intuitive Surgical, Inc.
Oct 2, 2013	Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 ...	A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu...	Class II	Intuitive Surgical, Inc.
Oct 2, 2013	REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance Syste...	It was discovered that the silicone potting failed to properly cure after undergoing the prescrib...	Class II	Stryker Instruments Div. of Stryker Corporation
Oct 2, 2013	MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for ...	Manufactured with an incorrect factory set unit of measure.	Class II	Nipro Diagnostics, Inc.
Oct 2, 2013	Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System...	Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, inclu...	Class II	Beckman Coulter Inc.
Oct 1, 2013	GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 1, 2013	GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 1, 2013	Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ...	There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio...	Class II	Omnyx Llc
Oct 1, 2013	Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry...	Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was...	Class II	Stryker Howmedica Osteonics Corp.
Oct 1, 2013	TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil...	Toshiba intitiated this recall because their investigation revealed that due to a problem of the ...	Class II	Toshiba American Medical Systems Inc
Oct 1, 2013	GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 1, 2013	Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3	InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I...	Class III	Helix Medical LLC
Sep 30, 2013	Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I...	Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c...	Class I	Merit Medical Systems, Inc.
Sep 30, 2013	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, mode...	Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program R...	Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in ...	Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive...	Class II	Draeger Medical, Inc.
Sep 30, 2013	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b...	During aging studies, the firm determined that the gastric belts were unable to pass the test req...	Class II	Ethicon Endo-Surgery Inc
Sep 30, 2013	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b...	During aging studies, the firm determined that the gastric belts were unable to pass the test req...	Class II	Ethicon Endo-Surgery Inc
Sep 30, 2013	Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM sur...	Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a...	Class II	Stryker Howmedica Osteonics Corp.
Sep 30, 2013	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr...	Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surg...	Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a...	Class II	Stryker Howmedica Osteonics Corp.
Sep 30, 2013	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr...	Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX0...	Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because...	Class I	Bard Peripheral Vascular Inc
Sep 30, 2013	Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P ...	A potential non conformance was identified with the Zero-P VA plate where the screw could back ou...	Class II	Synthes USA HQ, Inc.
Sep 30, 2013	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b...	During aging studies, the firm determined that the gastric belts were unable to pass the test req...	Class II	Ethicon Endo-Surgery Inc
Sep 27, 2013	TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm,...	Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures...	Class II	Olympus America Inc.
Sep 27, 2013	Breeze C Scooter is a motorized electric scooter for elderly people. Brand ...	Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it...	Class II	S.A.E. AFIKIM
Sep 27, 2013	OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US...	Alcohol Prep Pads contained within the kit are not properly labeled.	Class II	Insulet Corporation
Sep 27, 2013	OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:...	Alcohol Prep Pads contained within the kit are not properly labeled.	Class II	Insulet Corporation
Sep 27, 2013	B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 42...	One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is...	Class II	B. Braun Medical, Inc.
Sep 27, 2013	Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of ...	Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orie...	Class II	Cordis Corporation
Sep 26, 2013	3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ...	The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke...	Class II	OrthoPediatrics Corp
Sep 26, 2013	Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Di...	Distal Access Catheters were shipped to US customers with the Directions for Use that included in...	Class II	Concentric Medical Inc
Sep 26, 2013	HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonad...	Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm syst...	Class II	Hamilton Medical, Inc.
Sep 25, 2013	Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp...	Incomplete foil seal on one lot of sterile product.	Class II	Baxter Healthcare Corp.
Sep 25, 2013	Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon L...	Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab fai...	Class II	Ethicon, Inc.
Sep 24, 2013	Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81...	Handles and heads may not be compatible.	Class II	SpineFrontier, Inc.
Sep 24, 2013	Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short...	Multiple complaints have reported that the hex tip of the torque wrench fracturing during final t...	Class II	Stryker Spine
Sep 24, 2013	COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyz...	The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and C...	Class II	Beckman Coulter Inc.
Sep 24, 2013	Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates ea...	The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is ove...	Class II	Synthes USA HQ, 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.