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.

Date	Product	Reason	Class	Firm
Dec 16, 2013	Siemens Artis zee Ceiling Systems. Angiographic x-ray system.	During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub...	Class II	Siemens Medical Solutions USA, Inc
Dec 16, 2013	STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Ster...	Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S...	Class II	Advanced Sterilization Products
Dec 13, 2013	CODMAN CERTAS Programmable Valves, central nervous system shunt, models as fo...	Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray im...	Class II	Codman & Shurtleff, Inc.
Dec 13, 2013	King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King...	KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gas...	Class II	King Systems Corp.
Dec 13, 2013	SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10...	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark....	Class II	Highland Metals, Inc.
Dec 13, 2013	SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10...	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark....	Class II	Highland Metals, Inc.
Dec 13, 2013	B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used f...	Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow...	Class II	B. Braun Medical, Inc.
Dec 12, 2013	Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warme...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is inten...	On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual...	Class II	King Systems Corp.
Dec 12, 2013	Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthc...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled i...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 20...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122...	Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix...	Class II	GE Healthcare
Dec 12, 2013	GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging sys...	GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D,...	Class II	GE Healthcare, LLC
Dec 12, 2013	VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, St...	Sterility of medical devices intended for use in surgical procedures may be compromised.	Class II	Terumo Cardiovascular Systems Corporation
Dec 11, 2013	SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simvie...	In a very rare occurrence an intended movement of the SimView NT simulation system components cou...	Class II	Siemens Medical Solutions USA, Inc
Dec 11, 2013	AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identificat...	Kits incompatible with certain fluorescence microscope light sources	Class III	AdvanDx, Inc.
Dec 11, 2013	Latex Dental Dams labeled as Non-Latex Dental Dams	Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur...	Class II	Coltene Whaledent Inc
Dec 11, 2013	TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.	Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used ...	Class II	Toshiba American Medical Systems Inc
Dec 11, 2013	GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova...	GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno...	Class II	GE Healthcare, LLC
Dec 10, 2013	External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx...	The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fac...	Class II	BioHorizons Implant Systems Inc
Dec 10, 2013	Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r...	Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec...	Class II	Zimmer, Inc.
Dec 10, 2013	Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T...	MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev...	Class II	Philips Medical Systems, Inc.
Dec 10, 2013	Draeger Infinity Acute Care System Monitoring Solution	After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was ...	Class II	Draeger Medical Systems, Inc.
Dec 10, 2013	CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly...	Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec...	Class II	Zimmer, Inc.
Dec 10, 2013	Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip...	Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec...	Class II	Zimmer, Inc.
Dec 9, 2013	29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the Hi...	Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possibl...	Class II	Aesculap, Inc.
Dec 9, 2013	Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 20...	A sharp edge on the cannulated tip of the device may damage or cut a suture.	Class II	ArthroCare Medical Corporation
Dec 9, 2013	Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, ste...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile /...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit ins...	Improperly functioning component of a diagnostic medical device may cause false negative results ...	Class II	Becton Dickinson & Co.
Dec 9, 2013	23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Pa...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips...	Patient images exhibited ring artifacts.	Class II	Philips Medical Systems (Cleveland) Inc
Dec 9, 2013	25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, le...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, s...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetic...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics 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.