Medical DeviceSep 29, 2021
Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these recall — FDA Z-2496-2021
Incorrect version of labels were used.
Class IIFDA: TerminatedAd-Tech Medical Instrument Corporation
Recall records from September 2021
These records include useful source details for the selected month.
Medical DeviceSep 29, 2021
Microbiologics SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an recall — FDA Z-2487-2021
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceSep 29, 2021
Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white recall — FDA Z-2507-2021
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Class IIFDA: TerminatedGreiner Bio-One North America, Inc.
Medical DeviceSep 29, 2021
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog recall — FDA Z-2517-2021
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Class IIFDA: TerminatedSIGHT DIAGNOSTICS LTD
Medical DeviceSep 29, 2021
Beckman Coulter Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT recall — FDA Z-2508-2021
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2511-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2512-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System Tray Sysem knee implant devices as follows: Tray recall — FDA Z-2516-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
In2bones USA CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product recall — FDA Z-2506-2021
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Class IIFDA: TerminatedIn2bones USA, LLC
Medical DeviceSep 29, 2021
Philips Ultrasound EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and recall — FDA Z-2483-2021
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Class IIFDA: CompletedPhilips Ultrasound Inc.
Medical DeviceSep 29, 2021
Mac Medical Supply Co Ultrasound Gel labeled under the following brand names: MediChoice recall — FDA Z-2469-2021
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Class IFDA: OngoingMac Medical Supply Co Inc.
Medical DeviceSep 29, 2021
Philips Ultrasound Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and recall — FDA Z-2484-2021
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Class IIFDA: CompletedPhilips Ultrasound Inc.
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2510-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2515-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2513-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2514-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceSep 29, 2021
Medtronic Perfusion Systems DLP Left Heart Vent Catheters, 16 FR recall — FDA Z-2504-2021
Potential for a wire protrusion through the left heart vent catheter tip
Class IIFDA: OngoingMedtronic Perfusion Systems
Medical DeviceSep 29, 2021
Paragon 28 Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq recall — FDA Z-2488-2021
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Class IIFDA: TerminatedParagon 28, Inc.
Medical DeviceSep 29, 2021
Roche Molecular Systems cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat recall — FDA Z-2498-2021
Customers have reported an increased number of false positive SARS-CoV-2 results.
Class IIFDA: TerminatedRoche Molecular Systems, Inc.
Medical DeviceSep 29, 2021
Siemens Medical Solutions USA Computed tomography x-ray systems with software syngo.CT recall — FDA Z-2500-2021
Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceSep 29, 2021
GE Healthcare Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that recall — FDA Z-2502-2021
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceSep 29, 2021
Microbiologics SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an recall — FDA Z-2486-2021
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceSep 29, 2021
Olympus Corporation of the Americas EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No recall — FDA Z-2497-2021
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection…
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceSep 29, 2021
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting recall — FDA Z-2494-2021
Incorrect version of labels were used.
Class IIFDA: TerminatedAd-Tech Medical Instrument Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.