Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 49-30-260-035 Material Number: M00573020 recall — FDA Z-0778-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Monthly breakdown
2022 recalls by month
Select a month to review the recall records reported during that period.
December 2022318 records · 4 categoriesNovember 2022270 records · 4 categoriesOctober 2022288 records · 4 categoriesSeptember 2022318 records · 4 categoriesAugust 2022293 records · 4 categoriesJuly 2022334 records · 4 categoriesJune 2022348 records · 4 categoriesMay 2022227 records · 4 categoriesApril 2022205 records · 4 categoriesMarch 2022449 records · 4 categoriesFebruary 2022237 records · 4 categoriesJanuary 2022296 records · 4 categories
2022 recalls — page 113
Records are ordered by the best available source date.
Medical DeviceMar 23, 2022
Wright Medical Technology, Inc recall — FDA Z-0786-2022
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 49-30-450-035 Material Number: M00573030 recall — FDA Z-0779-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
SD Biosensor STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid recall — FDA Z-0719-2022
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
Class IFDA: OngoingSD Biosensor, Inc.
Medical DeviceMar 23, 2022
Boston Scientific Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material recall — FDA Z-0751-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 49-20MM/450CM Material Number: M00584020 recall — FDA Z-0756-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001 recall — FDA Z-0808-2022
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 recall — FDA Z-0766-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-20-260-025 Material Number: M00573080 recall — FDA Z-0768-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
CellEra 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box recall — FDA Z-0805-2022
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
Bard Peripheral Vascular Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" recall — FDA Z-0790-2022
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 22G X3.5 STRL recall — FDA Z-0796-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMar 23, 2022
Bio-Rad Laboratories BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL recall — FDA Z-0807-2022
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to…
Class IIFDA: OngoingBio-Rad Laboratories, Inc.
Medical DeviceMar 23, 2022
Bio-Rad Laboratories BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack recall — FDA Z-0806-2022
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to…
Class IIFDA: OngoingBio-Rad Laboratories, Inc.
Medical DeviceMar 23, 2022
Bard Peripheral Vascular LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP recall — FDA Z-0792-2022
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 44-30MM/450CM Material Number: M00583070 recall — FDA Z-0762-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Bard Peripheral Vascular ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY recall — FDA Z-0798-2022
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 LUMBARPUNCTURE TRAY ADULT recall — FDA Z-0797-2022
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 39-30-260-025 Material Number: M00573100 recall — FDA Z-0771-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Hologic Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion recall — FDA Z-0750-2022
Failed stability specifications for reagent kits that may result in false negative test results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-20-450-035 Material Number: M00573050 recall — FDA Z-0774-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-30-450-035 Material Number: M00573070 recall — FDA Z-0776-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-30-450-025 Material Number: M00573110 recall — FDA Z-0772-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-30-260-035 Material Number: M00573060 recall — FDA Z-0775-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
About the 2022 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.