Medical DeviceFeb 15, 2017
Invacare Foot Section - BAR5490IVC recall — FDA Z-1184-2017
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
Class IIFDA: TerminatedInvacare Corporation
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 988
28,065 detailed records are currently available in this category.
Medical DeviceFeb 15, 2017
Ortho-Clinical Diagnostics VITROS Chemistry Products UPRO Slides, UPN 10758750000593 recall — FDA Z-1179-2017
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceFeb 15, 2017
Angiodynamics Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the recall — FDA Z-1137-2017
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may…
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceFeb 15, 2017
Siemens Healthcare Diagnostics Dimension Vista Ammonia Flex reagent cartridge / AMM recall — FDA Z-1141-2017
Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceFeb 15, 2017
Vertebral Technologies InterFuse Tail Traction Tool, Part Number 9116 recall — FDA Z-1151-2017
Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.
Class IIFDA: TerminatedVertebral Technologies, Inc.
Medical DeviceFeb 15, 2017
Bayer Healthcare MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses recall — FDA Z-0927-2017
Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the…
Class IIFDA: TerminatedBayer Healthcare
Medical DeviceFeb 8, 2017
Immuno-Mycologics Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 recall — FDA Z-1109-2017
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported…
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1131-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Zimmer Biomet Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial recall — FDA Z-1114-2017
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 8, 2017
Siemens Healthcare Diagnostics IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog recall — FDA Z-1120-2017
Negative bias results with the IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceFeb 8, 2017
Implant Direct Sybron Manufacturing SwishTapered Implant recall — FDA Z-1112-2017
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead…
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing, LLC
Medical DeviceFeb 8, 2017
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA XRF Analyzer recall — FDA Z-1036-2017
It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not…
Class IIFDA: TerminatedOlympus Scientific Solutions Americas
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1129-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10 recall — FDA Z-1125-2017
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Class IIFDA: TerminatedCovidien LLC
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1132-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Siemens Medical Solutions USA Mammomat Inspiration full, field recall — FDA Z-1118-2017
Software error
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1130-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Medtronic Strata II / Strata NSC Valves recall — FDA Z-1121-2017
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the…
Class IIFDA: TerminatedMedtronic Neurosurgery
Medical DeviceFeb 8, 2017
Zimmer Biomet Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number recall — FDA Z-1115-2017
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1126-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1135-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Ortho-Clinical Diagnostics VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic recall — FDA Z-1117-2017
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1127-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
Medical DeviceFeb 8, 2017
Medtronic Advanced Energy Intact Disposable Wands recall — FDA Z-1133-2017
Product sterility compromised due to breach of sterile barrier
Class IIFDA: TerminatedMedtronic Advanced Energy, LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.