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
Aug 21, 2012 Covidien Duet TRS 60 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 60 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in lif... Class II Covidien LP
Aug 20, 2012 Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile t... The firm is recalling the products due to a potential for false negative test results. Class II Remel Inc
Aug 20, 2012 Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile t... The firm is recalling the products due to a potential for false negative test results. Class II Remel Inc
Aug 20, 2012 Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation ... Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have disco... Class II Abbott Vascular
Aug 20, 2012 Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO... Class III Microgenics Corporation
Aug 17, 2012 Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device... The firm recalled the device after learning of a possible deviation in the stimulus luminance of ... Class II Haag-Streit USA Inc
Aug 17, 2012 Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.... Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned H... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Vital Signs Disposable General Purpose 9 French Temperature Probe For monito... There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperat... Class II Vital Signs Colorado Inc.
Aug 16, 2012 KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manual... The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D... Class II Karl Storz Endoscopy America Inc
Aug 16, 2012 Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... Shipped with incorrect software Class II ZOLL Medical Corporation
Aug 16, 2012 GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst... GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21... Class II GE Healthcare, LLC
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 15, 2012 Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T... On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of ... Class II Sorin Group USA, Inc.
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wa... Class II Philips Healthcare Inc.
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 14, 2012 Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model ... Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can c... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 14, 2012 JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is i... Investigation found that the current design of the product allows the press-fit of the knob/shaft... Class II Biomet, Inc.
Aug 14, 2012 THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. ... The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and ... Class II Lansinoh Laboratories Inc
Aug 14, 2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (... Class II Philips Healthcare Inc.
Aug 13, 2012 Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 13, 2012 GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ... GE Healthcare became aware of a potential issue related to incorrect image measurement associated... Class II GE Healthcare, LLC
Aug 13, 2012 Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 13, 2012 Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Produ... Product was distributed with an incorrect expiration date. Product was labeled with an expiratio... Class II Neomend Inc
Aug 13, 2012 Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC... Vital Images has found two potential errors in calcium score values in restored snapshots of stud... Class II Vital Images, Inc.
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Pac... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box conta... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 MyRay RXDC dental unit x-ray unit The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30... Class II CEFLA DENTAL GROUP
Aug 10, 2012 IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboa... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number ... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 QKC1692E The QKC1692E Quick Connect device connects endoscopes to the ste... STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was una... Class II Steris Corporation
Aug 10, 2012 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 Capsule Neuron Docking Station, a component in the DataCaptor Connectivity Sy... Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or los... Class II Capsule Tech Inc.
Aug 9, 2012 Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable... There is potential for the sterility of the product to be compromised. Class II Intuitive Surgical, Inc.
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head R... T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-... Class II Integra LifeSciences Corporation
Aug 9, 2012 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vi... The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The s... Class II Encore Medical, Lp
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridg... Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibratio... Class II Siemens Healthcare Diagnostics, Inc.
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotac... T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-... Class II Integra LifeSciences Corporation

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.