Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Date	Product	Reason	Class	Firm
Dec 8, 2015	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name...	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post...	Class II	Synthes (USA) Products LLC
Dec 8, 2015	Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wiz...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 347...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name...	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post...	Class II	Synthes (USA) Products LLC
Dec 8, 2015	Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 T...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wiz...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive...	Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead ...	Class II	Synvasive Technology Inc
Dec 8, 2015	Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0...	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The...	Class II	Perkinelmer
Dec 8, 2015	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name...	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post...	Class II	Synthes (USA) Products LLC
Dec 8, 2015	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name...	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post...	Class II	Synthes (USA) Products LLC
Dec 8, 2015	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name...	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post...	Class II	Synthes (USA) Products LLC
Dec 8, 2015	AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 C...	The trial shell mating feature on the broach is undersized.	Class II	Encore Medical, Lp
Dec 7, 2015	GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us...	Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ...	Class II	GE Medical Systems, LLC
Dec 7, 2015	GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.	GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ...	Class II	GE Medical Systems, LLC
Dec 7, 2015	MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).	Possible installation error of the quench lines of superconducting magnets, used to vent helium g...	Class II	Siemens Medical Solutions USA, Inc
Dec 7, 2015	Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod ...	Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's la...	Class II	Innovasis, Inc
Dec 4, 2015	Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC...	The firm discovered that one of the hysteroscope models listed for processing in four existing Qu...	Class II	Steris Corporation
Dec 4, 2015	Model NuCARTGN. The NuCART is a mobile display and image management platform...	The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the secur...	Class II	CompView Medical, LLC
Dec 4, 2015	Synaptive Medical BrightMatter Navigator System (Guide System). Part number S...	Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicat...	Class II	Synaptive Medical, Inc.
Dec 3, 2015	Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3...	There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Al...	Class II	Smiths Medical ASD Inc.
Dec 3, 2015	VS300 radiographic Cassette Holder or Wall Stand. For use in radiology depart...	The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and...	Class II	Del Medical, Inc.
Dec 3, 2015	Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressur...	Potential for power cord to melt; hazards include electric shock and fire.	Class II	Stryker Medical Division of Stryker Corporation
Dec 3, 2015	BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemo...	Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv...	Class II	Becton Dickinson & Company
Dec 3, 2015	BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem...	Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv...	Class II	Becton Dickinson & Company
Dec 3, 2015	VS200 radiographic Cassette Holder or Wall Stand. For use in radiology depart...	The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and...	Class II	Del Medical, Inc.
Dec 3, 2015	BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem...	Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv...	Class II	Becton Dickinson & Company
Dec 3, 2015	MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusaha...	Cracking may occur at the 15mm and 22mm ISO female connector.	Class II	Teleflex Medical
Dec 3, 2015	Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The...	Stability data does not substantiate the labeled two-year shelf life of affected product.	Class II	Ethicon, Inc.
Dec 3, 2015	Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A he...	Cracks may occur at the 15mm and 22mm ISO female connector.	Class II	Teleflex Medical
Dec 3, 2015	BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD...	Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv...	Class II	Becton Dickinson & Company
Dec 3, 2015	NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and RE...	A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 ...	Class II	Zimmer Manufacturing B.V.
Dec 3, 2015	BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD...	Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv...	Class II	Becton Dickinson & Company
Dec 2, 2015	Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ...	Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag...	Class II	Medtronic
Dec 2, 2015	PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01...	The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical...	Class II	Gsi Group Inc
Dec 2, 2015	Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr...	Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag...	Class II	Medtronic
Dec 2, 2015	Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for di...	The hardware that holds the VESA plate and the display interface / monitor to the bracket may fai...	Class II	Skytron, Div. The KMW Group, Inc
Dec 2, 2015	Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR...	Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag...	Class II	Medtronic
Dec 2, 2015	Green Mamba Suture Passer	There may be a separation and an insufficient weld between the spring and washer. The weld betwe...	Class II	Biomet, Inc.
Dec 2, 2015	Black Mamba Suture Passer	There may be a separation and an insufficient weld between the spring and washer. The weld betwe...	Class II	Biomet, Inc.
Dec 2, 2015	Label reading in part as: "NexGen System, Complete Knee Solution; Reference N...	Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th...	Class II	Zimmer Manufacturing B.V.
Dec 2, 2015	Best Practice Kits containing certain production lots of Endo GIA Ultra Unive...	Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag...	Class II	Medtronic
Dec 1, 2015	MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Posit...	Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/...	Class II	Beckman Coulter Inc.
Dec 1, 2015	CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively...	Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood...	Class II	Partners In Medicine Llc
Dec 1, 2015	UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa...	Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ...	Class II	Beckman Coulter Inc.
Dec 1, 2015	QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets...	The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164...	Class II	Microbiologics Inc
Dec 1, 2015	MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan...	Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/...	Class II	Beckman Coulter Inc.
Dec 1, 2015	MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Posit...	Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/...	Class II	Beckman Coulter Inc.
Dec 1, 2015	UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Pa...	Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ...	Class II	Beckman Coulter 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.