Medical DeviceMar 23, 2022
Boston Scientific HYDRATOME RX 44-20MM/260CM Material Number: M00583040 recall — FDA Z-0759-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
March 2022 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceMar 23, 2022
Bard Peripheral Vascular LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 recall — FDA Z-0795-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Bard Peripheral Vascular LUMBAR PUNCTURE DRUG FREE TRAY 22G recall — FDA Z-0799-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Boston Scientific RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 recall — FDA Z-0780-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 recall — FDA Z-0767-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Abbott Laboratories Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI recall — FDA Z-0749-2022
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Class IIFDA: OngoingAbbott Laboratories, Inc.
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 44-30MM/450CM Material Number: M00584070 recall — FDA Z-0754-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 49-20-260-035 Material Number: M00573000 recall — FDA Z-0777-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Bard Peripheral Vascular SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT recall — FDA Z-0794-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 49-30MM/450CM Material Number: M00584030 recall — FDA Z-0758-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Siemens Medical Solutions USA Diagnostic Ultrasound System, ACUSON Juniper, UDI recall — FDA Z-0748-2022
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 49-20MM/260CM Material Number: M00584000 recall — FDA Z-0755-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
LivaNova Deutschland GmbH Sorin Centrifugal Pump System, CP5, Drive Unit recall — FDA Z-0787-2022
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Class IIIFDA: TerminatedLivaNova Deutschland GmbH
Medical DeviceMar 23, 2022
Bard Peripheral Vascular SAFE-T PLUS ATRAUMATIC ADULT LP TRAY recall — FDA Z-0800-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Bard Peripheral Vascular LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 recall — FDA Z-0791-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 recall — FDA Z-0765-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-20-450-025 Material Number: M00573090 recall — FDA Z-0769-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-30-260-025 Material Number: M00573100 recall — FDA Z-0770-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
CellEra 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box recall — FDA Z-0804-2022
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Class IIIFDA: TerminatedCellEra LLC
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 44-30MM/260CM Material Number: M00584050 recall — FDA Z-0753-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific HYDRATOME RX 49-20MM/260CM Material Number: M00583000 recall — FDA Z-0763-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Sam Medical Products SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 recall — FDA Z-0789-2022
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the…
Class IIFDA: TerminatedSam Medical Products
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-20-260-035 Material Number: M00573040 recall — FDA Z-0773-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Microbiologics LYFO Disk recall — FDA Z-0788-2022
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This…
Class IIIFDA: CompletedMicrobiologics Inc.
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.