Medical DeviceOct 5, 2022
bioMerieux VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx recall — FDA Z-0742-2022
Invalid calibrations (out of range high) while using the product.
Class IIFDA: TerminatedbioMerieux, Inc.
October 2022 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceOct 5, 2022
Mckesson Medical-Surgical Inc. Corporate Office Skin markers: a. IZI MEDICAL PRODUCTS LLC recall — FDA Z-1801-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceOct 5, 2022
CooperSurgical Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark recall — FDA Z-1822-2022
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
Class IIFDA: OngoingCooperSurgical, Inc.
Medical DeviceOct 5, 2022
Mckesson Medical-Surgical Inc. Corporate Office DERMARITE INDUSTRIES DermaCol 100 Collagen recall — FDA Z-1789-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceOct 5, 2022
CooperSurgical Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark recall — FDA Z-1823-2022
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
Class IIFDA: OngoingCooperSurgical, Inc.
Medical DeviceOct 5, 2022
Unomedical A/S Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820 recall — FDA Z-1810-2022
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Class IIFDA: TerminatedUnomedical A/S
Medical DeviceOct 5, 2022
Cook Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 recall — FDA Z-1832-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Cook Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY) recall — FDA Z-1824-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
CareFusion 303 BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with recall — FDA Z-1785-2022
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceOct 5, 2022
Mckesson Medical-Surgical Inc. Corporate Office a. SporView Culture Set SporView recall — FDA Z-1790-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceOct 5, 2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 recall — FDA Z-1848-2022
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the…
Class IIFDA: OngoingLeica Microsystems, Inc.
Medical DeviceOct 5, 2022
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 recall — FDA Z-1850-2022
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the…
Class IIFDA: OngoingLeica Microsystems, Inc.
Medical DeviceOct 5, 2022
Tandem Diabetes Care t:slim X2 insulin pump recall — FDA Z-1811-2022
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that…
Class IIFDA: OngoingTandem Diabetes Care Inc.
Medical DeviceOct 5, 2022
Cook Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN recall — FDA Z-1842-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Cook Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 recall — FDA Z-1840-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Cook Bentson Plus Wire Guide recall — FDA Z-1825-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Cook Newton Wire Guide recall — FDA Z-1836-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Mckesson Medical-Surgical Inc. Corporate Office DERMARITE INDUSTRIES SafeWash Saline Saline recall — FDA Z-1787-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceOct 5, 2022
Cook Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 recall — FDA Z-1844-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Cook Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN recall — FDA Z-1835-2022
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Class IIFDA: OngoingCook Inc.
Medical DeviceOct 5, 2022
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed recall — FDA Z-1777-2022
The packaging may not be sealed, which could compromise sterility.
Class IIFDA: OngoingCollagen Matrix Inc.
Medical DeviceOct 5, 2022
Mckesson Medical-Surgical Inc. Corporate Office Absorbent dressings. a recall — FDA Z-1803-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceOct 5, 2022
Baxter Healthcare Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product recall — FDA Z-1817-2022
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Class IIIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 5, 2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 recall — FDA Z-1786-2022
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure…
Class IIFDA: OngoingMicro-X Ltd.
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.