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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.

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DateProductReasonClassFirm
Nov 9, 2012 GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a ... GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data fr... Class II GE Healthcare, LLC
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 8, 2012 Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system... Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option ... Class II Toshiba American Medical Systems Inc
Nov 8, 2012 ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides ar... With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become awa... Class I Stryker Howmedica Osteonics Corp.
Nov 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Nov 8, 2012 EnteraLite Infinity Enteral Feeding Pump identified with the following list n... MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the E... Class II MOOG Medical Devices Group
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Trea... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diame... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 Analyzing system consists of a small and portable analyzer and plastic microc... Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... Class III HemoCue AB
Nov 7, 2012 Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hai... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hyd... Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report... Class II IDS (Immunodiagnostic Systems Ltd.)
Nov 6, 2012 Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous ... It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it... Class II Biomet, Inc.
Nov 6, 2012 Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bip... Potential for self activation while the device is in use, which may result in unintended thermal ... Class II Ethicon Endo-Surgery Inc
Nov 6, 2012 BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton,... An antibiotic susceptibility test kit may produce false intermediate or false resistant results w... Class II Becton Dickinson & Co.
Nov 6, 2012 Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and ... Following their receipt of several customer complaints, Invacare recalled their height adjustable... Class II Invacare Corporation
Nov 5, 2012 SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Nov 5, 2012 Laparoscope, general; plastic surgery Used for general, abdominal, gynecol... Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shi... Class II Applied Medical Resources Corp
Nov 5, 2012 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, ... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Ther... This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and ... Class II Arobella Medical, LLC
Nov 5, 2012 SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Nov 5, 2012 Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMW... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The ... An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v... Class II Integra LifeSciences Corporation
Nov 5, 2012 Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of... One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was includ... Class II Ansell Healthcare Products LLC
Nov 5, 2012 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay... Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of... Class II Beckman Coulter Inc.
Nov 5, 2012 MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) i... An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v... Class II Integra LifeSciences Corporation
Nov 5, 2012 Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiat... Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiat... Class II Varian Medical Systems, Inc. Oncology Systems
Nov 5, 2012 OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC Th... Failure of glue joint, allowed a portion of the single use device to shift inside, may separate a... Class II OmniGuide, Inc.
Nov 5, 2012 MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... Class II Medrad Inc
Nov 2, 2012 Synthes Trauma Nail System. The devices are indication for bone fixation. Recall was initiated due to the possibility that the outer pouch was compromised. The product is... Class II Synthes USA HQ, Inc.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 device... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 B... There is a potential issue with the screw tension of the extension device 1433.62A1 used with the... Class II Maquet Inc.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S12... California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. D... Class II California Medical Laboratories Inc
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/c... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue)... Additional Warning Statement to prevent burns to the skin Class II Brookstone Company, Inc.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to ... California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. D... Class II California Medical Laboratories Inc
Nov 2, 2012 BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthe... The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals t... Class II Del Mar Reynolds Medical, Ltd.

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.