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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

FDA Recall
Open, Classified ·Smiths Medical Asd Inc·Product code DRS·November 10, 2023

INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

FDA Recall
Open, Classified ·PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR·Product code QMN·October 25, 2023

Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113A

FDA Recall
Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

FDA Recall
Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 13, 2023

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

FDA Recall
Open, Classified ·Natus Medical Incorporated·Product code JXG·November 28, 2023

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

FDA Recall
Completed ·Product code PHX·October 5, 2023

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

FDA Recall
Completed ·Product code PHX·October 5, 2023

Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·November 3, 2023

CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A

FDA Recall
Open, Classified ·CardioQuip, LLC·Product code DWC·October 24, 2023

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Recall
Open, Classified ·Exactech, Inc.·Product code KWS·March 6, 2024