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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.

28,065medical device recall records

2,353FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 965

28,065 detailed records are currently available in this category.

Medical DeviceApr 12, 2017

Beckman Coulter Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 recall — FDA Z-1709-2017

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceApr 12, 2017

Agilent Technologies Bond Elut OMS (Dried Matrix Spotting)' Product recall — FDA Z-1737-2017

The product was marketed without 510(k) clearance.

Class IIFDA: TerminatedAgilent Technologies, Inc.

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1725-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1724-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1720-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1723-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Centurion Medical Products OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are recall — FDA Z-1735-2017

Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceApr 12, 2017

Centurion Medical Products OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are recall — FDA Z-1732-2017

Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceApr 12, 2017

Centurion Medical Products POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are recall — FDA Z-1730-2017

Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceApr 12, 2017

Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The recall — FDA Z-1740-2017

Product sterility is compromised due to breach of sterile barrier

Class IIFDA: TerminatedCovidien LLC

Medical DeviceApr 12, 2017

Philips Visicu eCare Coordinator Product Usage: is software intended for use in data recall — FDA Z-1708-2017

eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and…

Class IIFDA: TerminatedPhilips Visicu

Medical DeviceApr 12, 2017

Centurion Medical Products POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval recall — FDA Z-1734-2017

Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1717-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride recall — FDA Z-1743-2017

Product sterility is compromised due to breach of sterile barrier

Class IIFDA: TerminatedCovidien LLC

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1716-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1721-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part recall — FDA Z-1707-2017

Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful…

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceApr 12, 2017

BioMerieux SA NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be recall — FDA Z-1713-2017

Problem with colored eluates for whole blood extractions

Class IIFDA: TerminatedBioMerieux SA

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1719-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceApr 12, 2017

Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for recall — FDA Z-1747-2017

Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceApr 12, 2017

Philips Medical Systems (Cleveland) BrightView SPECT model number 882480 BrightView and recall — FDA Z-1750-2017

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceApr 12, 2017

Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR recall — FDA Z-1749-2017

Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceApr 12, 2017

Centurion Medical Products EYE KIT The Covidien Curity Oval Eye Pads are individually recall — FDA Z-1733-2017

Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceApr 12, 2017

Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1729-2017

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…

Class IIFDA: TerminatedIntuitive Surgical, 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.