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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,963medical device recall records

2,598FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1201

29,963 detailed records are currently available in this category.

Medical DeviceApr 15, 2015

Lusys Laboratories Ebola Virus Antigen Nasal , Catalog No recall — FDA Z-1333-2015

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or…

Class IFDA: TerminatedLusys Laboratories, Inc.

Medical DeviceApr 15, 2015

Biomerieux Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per recall — FDA Z-1401-2015

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Class IIIFDA: TerminatedBiomerieux Inc.

Medical DeviceApr 15, 2015

Lusys Laboratories Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No recall — FDA Z-1328-2015

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or…

Class IFDA: TerminatedLusys Laboratories, Inc.

Medical DeviceApr 15, 2015

Lusys Laboratories Ebola Accessories assembled, self-contained package, Catalog No recall — FDA Z-1332-2015

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or…

Class IFDA: TerminatedLusys Laboratories, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack recall — FDA Z-1381-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Teleflex Medical Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal recall — FDA Z-1404-2015

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceApr 15, 2015

Bacterin International Instrument Kit for use with OsteoSponge SC grafts recall — FDA Z-1396-2015

Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits.…

Class IIFDA: TerminatedBacterin International, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Camera Drape, 20 Pack recall — FDA Z-1382-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 recall — FDA Z-1392-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack recall — FDA Z-1383-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack recall — FDA Z-1386-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 recall — FDA Z-1393-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C recall — FDA Z-1408-2015

A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

Class IIFDA: TerminatedVasoNova, Inc.

Medical DeviceApr 15, 2015

CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label recall — FDA Z-1397-2015

Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

Class IIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack recall — FDA Z-1384-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Carestream Health CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to recall — FDA Z-1377-2015

Units device head descended unexpectedly

Class IIFDA: TerminatedCarestream Health, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Arm Drape, 20 Pack recall — FDA Z-1380-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Carestream Health CS 8100 3D, CATALOG # (s): 5311162, 5311188 recall — FDA Z-1378-2015

Units device head descended unexpectedly

Class IIFDA: TerminatedCarestream Health, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack recall — FDA Z-1391-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Siemens Healthcare Diagnostics ADVIA Chemistry XPT System, Siemens Material Number 10723034 recall — FDA Z-1399-2015

Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 recall — FDA Z-1387-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Biomerieux Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per recall — FDA Z-1403-2015

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Class IIIFDA: TerminatedBiomerieux Inc.

Medical DeviceApr 15, 2015

Intuitive Surgical da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 recall — FDA Z-1389-2015

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 15, 2015

Toshiba American Medical Systems INFX-8000V Interventional Angiography System recall — FDA Z-1394-2015

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

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.