Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Date	Product	Reason	Class	Firm
Dec 18, 2017	COACH¿ Self-Adhering Sports Wrap (size: 2in)	Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in...	Class II	Johnson & Johnson Consumer, Inc.
Dec 15, 2017	Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffi...	During collimator exchange, the alignment of the collimator cart and detectors may cause a collim...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2017	ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: ...	Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize...	Class II	Arrow International Inc
Dec 15, 2017	Alere iScreen Dx Urine Drug Screen Card	The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti...	Class III	Ameditech Inc
Dec 15, 2017	BrightView X, Model #882478 Product Usage: BrightView and BrightView X a...	During collimator exchange, the alignment of the collimator cart and detectors may cause a collim...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2017	BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma came...	During collimator exchange, the alignment of the collimator cart and detectors may cause a collim...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2017	Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in...	The calibration for the affected batch of analyzers was incorrectly set during the manufacturing ...	Class II	Quidel Corporation
Dec 15, 2017	Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin...	During collimator exchange, the alignment of the collimator cart and detectors may cause a collim...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2017	BrightView Model 882480 Product Usage: BrightView and BrightView X are g...	During collimator exchange, the alignment of the collimator cart and detectors may cause a collim...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2017	Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01...	Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr...	Class II	DePuy Spine, Inc.
Dec 15, 2017	Camera System, Television, Surgical without audio Intended for transmissio...	The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits...	Class II	Trumpf Medical Systems, Inc.
Dec 15, 2017	Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Pro...	if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected...	Class II	GE Healthcare, LLC
Dec 15, 2017	Uterine Electromyographic Monitor -Monica IF24 Interface System Product Us...	if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected ...	Class II	GE Healthcare, LLC
Dec 14, 2017	ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar...	Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from ...	Class II	Abbott Gmbh & Co. KG
Dec 14, 2017	Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, pho...	Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimen...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 14, 2017	2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial...	When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service ...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 14, 2017	PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, C...	Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP ...	Class II	Merit Medical Systems, Inc.
Dec 14, 2017	Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded...	Torn sheath liner material was detected at the proximal end of the device during internal product...	Class II	Kalila Medical
Dec 14, 2017	Dynavox T15 Speech Generating Device ( including Batteries)	The battery is integral to the device. If the device sits unused and is not charged for a length...	Class II	Dynavox Systems Llc
Dec 14, 2017	DermaPro Waterproof Silicone Tape, SNS57232	The recalling firm received a customer complaint stating the tape was difficult to peel off the r...	Class II	Safe N Simple, LLC
Dec 14, 2017	Dynavox T10 Speech Generating Device ( including Batteries)	The battery is integral to the device. If the device sits unused and is not charged for a length...	Class II	Dynavox Systems Llc
Dec 14, 2017	Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is w...	Torn sheath liner material was detected at the proximal end of the device during internal product...	Class II	Kalila Medical
Dec 13, 2017	CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagne...	The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with A...	Class II	Halyard Health, Inc
Dec 13, 2017	11-VI Incorporated Laser diode component Non-certified laser diode compone...	Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.	Class II	Ii - Vi Incorporated
Dec 13, 2017	Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401...	In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted ...	Class II	Smith & Nephew, Inc.
Dec 13, 2017	Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22...	Foley Catheter with Incorrect Retainer Cap Print	Class II	C.R. Bard, Inc.
Dec 13, 2017	Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia...	Product reportedly shutting down during use.	Class II	Covidien LLC
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Q...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE,...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated fo...	A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no s...	Class II	Zimmer Biomet, Inc.
Dec 12, 2017	Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 087147...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qt...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Q...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 ...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 11, 2017	digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/...	It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may ...	Class II	Philips Electronics North America Corporation
Dec 11, 2017	Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This d...	A software issue causes PET reconstructions to fail intermittently. It was determined that recons...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 11, 2017	smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating...	Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-...	Class II	Smith & Nephew, Inc.
Dec 11, 2017	Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a ne...	Potential polymer material degradation.	Class II	Boston Scientific Corporation
Dec 11, 2017	Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015	Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ...	Class II	Smith & Nephew, Inc.
Dec 11, 2017	Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels p...	Product sterility potentially compromised.	Class II	Medical Action Industries Inc
Dec 11, 2017	Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us...	Contamination with Methylbacterium thiocyanatum	Class II	Sanofi Genzyme
Dec 11, 2017	smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating...	Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-...	Class II	Smith & Nephew, Inc.
Dec 8, 2017	ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 8, 2017	Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. ...	The serum may fail to agglutinate within the specified minimum reaction time.	Class II	Remel Inc
Dec 8, 2017	Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revisi...	Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ...	Class II	Zimmer Biomet, Inc.
Dec 8, 2017	MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Acc...	Due to a system controller software anomaly, the patient positioning deviation correction may not...	Class II	Hitachi Ltd., Medical System Operations Group

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.