Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Date	Product	Reason	Class	Firm
Dec 14, 2016	NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection m...	Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk beca...	Class II	Ultradent Products, Inc.
Dec 14, 2016	16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:...	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi...	Class II	MEDLINE INDUSTRIES INC
Dec 14, 2016	12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl...	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi...	Class II	MEDLINE INDUSTRIES INC
Dec 14, 2016	16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ...	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi...	Class II	MEDLINE INDUSTRIES INC
Dec 14, 2016	14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl...	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi...	Class II	MEDLINE INDUSTRIES INC
Dec 14, 2016	SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recov...	Organ preservation fluid recalled due to potential for bacterial contamination.	Class II	Organ Recovery Systems, Inc.
Dec 13, 2016	Roth Net Polyp Retrieval	The firm was notified that the expiration date on the outer carton is different than the expirati...	Class III	US Endoscopy Group Inc
Dec 13, 2016	Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Bi...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mC...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Chord-X Chordal Sizer is designed to assist in determining the proper length ...	Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Lef...	Class II	On-X Life Technologies, Inc.
Dec 13, 2016	Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT an...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT ...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT an...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Bi...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT an...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p...	One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ...	Class II	Boston Scientific Corporation
Dec 13, 2016	Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT an...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT an...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst...	Software issue	Class II	Ion Beam Applications S.A.
Dec 13, 2016	Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biogra...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 13, 2016	Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph...	Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las...	Class II	Siemens Medical Solutions USA Inc.
Dec 12, 2016	Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9...	Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngost...	Class II	Pentax of America Inc
Dec 12, 2016	URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope	Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) bu...	Class II	Olympus Corporation of the Americas
Dec 12, 2016	Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The U...	Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending ...	Class II	Olympus Corporation of the Americas
Dec 12, 2016	Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL ...	Product was not sterilized. Product was shipped to distribution centers instead of the sterilizat...	Class II	MEDLINE IND
Dec 12, 2016	Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Bloo...	The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially ...	Class II	Great Basin Scientific, Inc.
Dec 12, 2016	AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG...	Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Pr...	Class II	Medtronic Navigation, Inc.
Dec 12, 2016	SwishTapered Implant	The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; L...	Class II	Implant Direct Sybron Manufacturing, LLC
Dec 9, 2016	Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStat...	This recall has been initiated due to an issue related to the potential accidental deletion of re...	Class II	Merge Healthcare, Inc.
Dec 9, 2016	Velara Generator with an old Firmware version used with Philips Allura Xper S...	System may lock up.	Class II	Philips Electronics North America Corporation
Dec 9, 2016	Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M...	During internal testing conducted as part of next generation product development, it was discover...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Dec 9, 2016	I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive ...	Activity and quantity of seeds sent in shipments were incorrect.	Class II	C.R. Bard, Inc.
Dec 9, 2016	StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a s...	Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization D...	Class II	Bard Access Systems
Dec 9, 2016	Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri...	The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co...	Class II	Smiths Medical ASD Inc.
Dec 9, 2016	Velara Generator with an old Firmware version used with the Philips Integris ...	System may lock up.	Class II	Philips Electronics North America Corporation
Dec 9, 2016	Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinSt...	Merge received reports of Merge Eye Station being unable to capture images of the eye as expected...	Class II	Merge Healthcare, Inc.
Dec 9, 2016	StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged ...	Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization D...	Class II	Bard Access Systems
Dec 8, 2016	Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis syst...	Siemens initiated a corrective action to address two possible, mutually independent causes of a s...	Class II	Siemens Medical Solutions USA, Inc
Dec 8, 2016	Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis sys...	Siemens initiated a corrective action to address two possible, mutually independent causes of a s...	Class II	Siemens Medical Solutions USA, Inc
Dec 8, 2016	VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usag...	There is a potential for variable negatively and positively biased urine protein results using VI...	Class II	Ortho-Clinical Diagnostics
Dec 8, 2016	Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O ...	Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a pri...	Class II	Trilliant Surgical Ltd.
Dec 7, 2016	Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small S...	The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou...	Class II	Stanmore Implants Worldwide Ltd.
Dec 7, 2016	Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The prod...	The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou...	Class II	Stanmore Implants Worldwide Ltd.
Dec 7, 2016	DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem ...	The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou...	Class II	Stanmore Implants Worldwide Ltd.
Dec 7, 2016	DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or...	CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.	Class II	Cardiovascular Systems Inc
Dec 7, 2016	Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480...	Damaged packaging, lack of sterility assurance	Class II	Medacta Usa Inc
Dec 7, 2016	Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste...	The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou...	Class II	Stanmore Implants Worldwide Ltd.
Dec 7, 2016	Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small S...	The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou...	Class II	Stanmore Implants Worldwide Ltd.
Dec 6, 2016	Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134...	A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.	Class II	Stryker Sustainability Solutions
Dec 6, 2016	Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab...	A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.	Class II	Stryker Sustainability Solutions

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.