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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

24,239medical device recall records

2,205FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.751 records

Database records

Records — page 445

24,239 detailed records are currently available in this category.

Medical DeviceMar 23, 2022

Boston Scientific Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material recall — FDA Z-0752-2022

Sterility of device is compromised due to a sterile barrier breach

Class IIFDA: OngoingBoston Scientific Corporation

Medical DeviceMar 23, 2022

CellEra 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box recall — FDA Z-0803-2022

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 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 recall — FDA Z-0764-2022

Sterility of device is compromised due to a sterile barrier breach

Class IIFDA: OngoingBoston Scientific Corporation

Medical DeviceMar 23, 2022

CellEra 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box recall — FDA Z-0801-2022

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 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 recall — FDA Z-0781-2022

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

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 44-30-450-035 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 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

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 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

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

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

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 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

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

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

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

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

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

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

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

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 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

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.