Medical DeviceApr 12, 2017
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity recall — FDA Z-1742-2017
Product sterility is compromised due to breach of sterile barrier
Class IIFDA: TerminatedCovidien LLC
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 964
28,065 detailed records are currently available in this category.
Medical DeviceApr 12, 2017
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay recall — FDA Z-1748-2017
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
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1714-2017
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 CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are recall — FDA Z-1736-2017
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 Item Code: 91650 The sterile eye pad is a device that consists of a recall — FDA Z-1741-2017
Product sterility is compromised due to breach of sterile barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceApr 12, 2017
Beckman Coulter Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product recall — FDA Z-1710-2017
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
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1715-2017
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 Medical Systems (Cleveland) BrightView XCT model number 882482 BrightView and recall — FDA Z-1751-2017
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
Philips Medical Systems (Cleveland) BrightView X 3/4 model number 882479 BrightView and recall — FDA Z-1752-2017
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 Healthcare Diagnostics ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture recall — FDA Z-1712-2017
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase…
Class IIIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 12, 2017
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1728-2017
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
AGFA Healthcare DX-D600 - DXD Imaging Package recall — FDA Z-1738-2017
One of the dent markers from the DX-D600 dropped down from the overhead rail.
Class IIFDA: TerminatedAGFA Healthcare Corp.
Medical DeviceApr 12, 2017
Philips Healthcare Mobile Diagnostic X-Ray System with Digital Panel recall — FDA Z-1706-2017
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
Class IIFDA: TerminatedPhilips Healthcare Inc.
Medical DeviceApr 12, 2017
Arrow International The CG+ Arrow PIC Catheters permit venous access to the central recall — FDA Z-1705-2017
Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceApr 12, 2017
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1726-2017
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-1718-2017
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-1722-2017
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
Beckman Coulter UniCel DxC 600i SYNCHRON Access Clinical System, Part No recall — FDA Z-1711-2017
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
Philips Medical Systems (Cleveland) BrightView X 3/8 model number 882478 BrightView and recall — FDA Z-1753-2017
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 IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceApr 12, 2017
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1727-2017
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
Becton Dickinson & Company BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection recall — FDA Z-1746-2017
BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots…
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceApr 12, 2017
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No recall — FDA Z-1704-2017
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceApr 12, 2017
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a recall — FDA Z-1739-2017
Product sterility is compromised due to breach of sterile barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceApr 12, 2017
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity recall — FDA Z-1745-2017
Product sterility is compromised due to breach of sterile barrier
Class IIFDA: TerminatedCovidien 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.