Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

Clear

Date	Product	Reason	Class	Firm
Sep 4, 2012	DTO" Implant	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar...	Class II	Zimmer, Inc.
Sep 4, 2012	NCB¿ screw ¿ 4.0 self-tapping	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar...	Class II	Zimmer, Inc.
Sep 4, 2012	Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar...	Class II	Zimmer, Inc.
Sep 3, 2012	UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel...	Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment proce...	Class II	Beckman Coulter Inc.
Aug 31, 2012	Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usa...	Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001...	Class II	Zimmer, Inc.
Aug 31, 2012	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro M...	Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at ti...	Class II	Accuro Medical Product LLC
Aug 31, 2012	Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Modu...	Posterior fluidics modules installed in the system may need to be recalibrated.	Class II	Bausch & Lomb Inc
Aug 31, 2012	The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i...	Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,...	Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr...	Class II	Vascular Solutions, Inc.
Aug 30, 2012	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Throm...	Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.	Class II	Stryker Sustainability Solutions
Aug 29, 2012	T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-hand...	During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.	Class II	SpineFrontier, Inc.
Aug 29, 2012	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Rem...	Sterility of the product may be compromised.	Class II	Remington Medical Inc.
Aug 29, 2012	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini...	The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,...	Class I	Hospira Inc.
Aug 29, 2012	Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini...	The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,...	Class I	Hospira Inc.
Aug 28, 2012	TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model nu...	The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the meta...	Class II	Kardium
Aug 28, 2012	Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination...	SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standa...	Class II	Sekisui Diagnostics Llc
Aug 28, 2012	The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B...	Philips was notified that the system logout in software version 2.3.6 is now longer and may somet...	Class III	Philips Medical Systems (Cleveland) Inc
Aug 28, 2012	Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compresso...	Inspan Compressors may break at weld causing a loss of compression	Class II	SpineFrontier, Inc.
Aug 28, 2012	Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers a...	Embedded iron oxide glass defect which may have the potential to break off into the solution.	Class II	Hospira Inc.
Aug 28, 2012	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durha...	The instrument may not dispense the specimen onto the pre-poured media resulting in a false negat...	Class II	Biomerieux Inc
Aug 27, 2012	Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is int...	There is a potential failure of the Integrated Module Housing causing the patient module paramete...	Class II	Spacelabs Healthcare, Llc
Aug 27, 2012	Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser...	Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p...	Class II	Zimmer, Inc.
Aug 24, 2012	Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft,...	Implants were incorrectly laser marked as 23mm instead of 28mm.	Class II	Spine Smith Partners LP
Aug 24, 2012	Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Versio...	The display on the system has the potential to change. In house testing eventually identified the...	Class II	Volcano Corporation
Aug 24, 2012	MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT S...	On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 24, 2012	The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Exten...	Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension...	Class II	Iradimed Corporation
Aug 23, 2012	Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia b...	King Systems received a customer complaint indicating that the customer had ordered a breathing c...	Class I	King Systems Corp.
Aug 23, 2012	Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity...	Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl...	Class II	Biomet, Inc.
Aug 23, 2012	Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity...	Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl...	Class II	Biomet, Inc.
Aug 22, 2012	12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL ...	Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.	Class II	Smith & Nephew Inc
Aug 22, 2012	Dual Tip Marker, Sterile Product Usage: A writing instrument intended...	Dual Tip Marker has inconsistent ink flow on the black permanent ink side.	Class III	Viscot Medical LLC
Aug 22, 2012	S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223...	When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a kno...	Class II	SpineFrontier, Inc.
Aug 22, 2012	S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ...	Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus...	Class II	DePuy Orthopaedics, Inc.
Aug 21, 2012	Siemens Mobilett Mira. Mobile X-Ray System.	During regular product monitoring, Siemens has become aware of a potential issue with the Mobilet...	Class II	Siemens Medical Solutions USA, Inc
Aug 21, 2012	Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, package...	The firm is recalling the product because the cartridges may contain discs that have an insuffici...	Class II	Remel Inc
Aug 21, 2012	Oncentra External Beam 4.1. Radiation treatment planning software designed...	During the planning process the beam weights can be changed by the customers. When the beam weigh...	Class II	Elekta, Inc.
Aug 21, 2012	Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Produ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer...	SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi...	Class I	Ethicon, Inc.
Aug 21, 2012	Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ...	A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 21, 2012	Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed...	SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi...	Class I	Ethicon, Inc.
Aug 21, 2012	Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0...	The firm is recalling the product due to some cartridges may contain individual discs that are no...	Class II	Remel Inc
Aug 21, 2012	Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device**STERILE...	Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified bl...	Class I	Vycor Medical, Inc.
Aug 21, 2012	Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP

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.