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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 9, 2012 | AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, O... | The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15... | Class II | AmeriWater Inc |
| Aug 9, 2012 | Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine... | Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... | Class II | Stryker Spine |
| Aug 9, 2012 | Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... | Class II | Applied Medical Resources Corp |
| Aug 9, 2012 | AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMSt... | Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore ... | Class II | AGFA Corp. |
| Aug 9, 2012 | Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... | Class II | Applied Medical Resources Corp |
| Aug 9, 2012 | Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pin... | Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... | Class II | Stryker Spine |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 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 | SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE ... | Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... | Class II | Stryker Spine |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 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 5 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 8, 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 8, 2012 | AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyva... | Complaints associated with an unexpected stop in AutoPulse compressions. | Class II | Zoll Circulation, Inc. |
| Aug 8, 2012 | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). ... | Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from th... | Class II | Parks Medical Electronics, Inc |
| Aug 7, 2012 | GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The s... | GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx,... | Class II | GE Healthcare, LLC |
| Aug 7, 2012 | ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 7, 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 7, 2012 | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters be... | Class III | Bard Access Systems |
| Aug 6, 2012 | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic D... | Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal... | Class II | Nidek Inc |
| Aug 6, 2012 | Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... | Although the reported incidence is low, there is the potential for the drill stop to slip on the ... | Class II | Synthes USA HQ, Inc. |
| Aug 6, 2012 | Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... | Although the reported incidence is low, there is the potential for the drill stop to slip on the ... | Class II | Synthes USA HQ, Inc. |
| Aug 6, 2012 | Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporati... | On August 6, 2012, Invacare voluntarily recalled the Invacare¿ I-Fit" Shower Chair (Models 9780, ... | Class II | Invacare Corporation |
| Aug 6, 2012 | Precise Digital Accelerator Delivery of radiation to defined target volumes | There have been a small number of instances in hospitals where the joint between the drive gear a... | Class II | Elekta, Inc. |
| Aug 6, 2012 | Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distra... | There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during... | Class II | Orthofix, Inc |
| Aug 6, 2012 | The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diame... | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering hi... | Class II | Diamedix Corporation |
| Aug 6, 2012 | ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically tran... | The seat could break as a result of damage resulting from a seat belt being trapped underneath th... | Class II | ThyssenKrupp Access Corp |
| Aug 6, 2012 | Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile;... | During the manufacturing of the affected lot a manufacturing error has led to embrittlement of th... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ... | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Aug 3, 2012 | Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: ... | Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXI... | Class I | Ethicon Endo-Surgery Inc |
| Aug 3, 2012 | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System | GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Mode... | Class II | GE Healthcare, LLC |
| Aug 3, 2012 | The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ra... | The patient support may move in an unintended manner if the foot switch cover becomes damaged and... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 3, 2012 | Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set wi... | Devices leaking at the Y-site | Class II | Medical Specialties Distributors, Inc. |
| Aug 3, 2012 | Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. ... | May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a compo... | Class I | Newport Medical Instruments Inc |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) ... | Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; an... | Class II | Covidien LLC |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental I... | Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percen... | Class II | Biomet 3i, LLC |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Class II | Instrumentation Laboratory Co. |
| Aug 2, 2012 | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... | On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... | Class III | Steris Corporation |
| Aug 2, 2012 | E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology | An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the... | Class II | Kreg Medical Inc. |
| Aug 2, 2012 | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-0... | Reports of leaking during filling and administration. | Class II | Hospira, Inc. |
| Aug 2, 2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ... | Customers were not following the labeled assay procedure. This was due to a letter issued to them... | Class III | Phadia US Inc |
| Aug 1, 2012 | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Ste... | The firm initiated a recall after complaint investigations revealed that when the units are left ... | Class II | Steris Corporation |
| Aug 1, 2012 | DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kit... | Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grou... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Jul 31, 2012 | DePuy Custom Implant Devices Packaging: Packaging was not standardized o... | In connection with a Warning Letter received from the U.S. Food & Drug Administration on December... | Class II | DePuy Orthopaedics, 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.