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
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 444
24,239 detailed records are currently available in this category.
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 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
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 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
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
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
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
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
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 49-30MM/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
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 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
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
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 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
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
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
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
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
Medical DeviceMar 23, 2022
Bard Peripheral Vascular ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G recall — FDA Z-0793-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
CellEra 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box recall — FDA Z-0802-2022
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 49-30MM/260CM Material Number: M00584010 recall — FDA Z-0757-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Hill-Rom (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift recall — FDA Z-0783-2022
Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail…
Class IIFDA: TerminatedHill-Rom, 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.