BEUDAMED
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    Filters FDA Recall × Status: Open, Classified × Clear all

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    TMJ Bilateral Implants, REF: CHG020

    FDA Recall
    Open, Classified ·TMJ Solutions Inc·Product code LZD·February 11, 2026

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code LZD·December 6, 2022

    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·March 29, 2024

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Recall
    Open, Classified ·Osteomed, LLC·Product code KMW·October 28, 2021

    3M Durapore Surgical Tape, Catalog Number 1538-118

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code KGX·March 20, 2024

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·December 11, 2024

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·May 12, 2023

    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·August 20, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·December 26, 2023

    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FMF·August 8, 2023

    Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code FMF·September 20, 2023

    Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Recall
    Open, Classified ·Jiangsu Shenli Medical Production Co., Ltd. No.·Product code FMF·April 5, 2024

    Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Recall
    Open, Classified ·Jiangsu Shenli Medical Production Co., Ltd. No.·Product code FMF·April 5, 2024