The Recall Desk

Hazard

Medical Device Defect recalls

33 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
33
Critical
0
Severe
1
Most recent
2026-08-12

Of the 33 medical device defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all medical device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 33

  • HighFDA (Devices)·Z-2884-2026·2026-08-12

    USTAR II Knee System Hinge Box Trial Recall

    United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.

    Product
    Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2026·2026-05-13

    BioCera Fibers Bioresorbable Bone Void Filler Recall

    Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because the product falls outside standard specifications. The recall affects 1266 units distributed nationwide in California and Florida.

    Product
    BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2026·2026-03-04

    Hitachi Proton Beam Therapy System Recalled Due to Software Anomaly

    Hitachi is recalling its Proton Beam Therapy system due to a software anomaly in the patient positioning system that may cause positional discrepancies during treatment.

    Product
    Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0467-2025·2024-11-27

    Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment

    Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3159-2024·2024-09-25

    Convenience kits recalled for containing defective medical syringes

    ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.

    Product
    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3030-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries is recalling multiple medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2899-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2816-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled nationwide

    Procedure packs containing Sol-M manufactured syringes are being voluntarily recalled nationwide. The affected product is part number 58000603.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000603;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2024·2024-06-12

    Medline Luer Slip Syringes Recalled for Inaccurate Volume Delivery

    Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.

    Product
    MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2024·2024-01-03

    DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers

    DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.

    Product
    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1849-2023·2023-07-05

    Flexi-Set Endotracheal Tubes recalled for connector disconnection

    Teleflex is recalling over 1 million Flexi-Set Cuffed Endotracheal Tube kits due to reports of 15mm connector disconnection from the tube. The recall affects products distributed nationwide.

    Product
    Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0668-2023·2022-12-21

    DeRoyal Facial Pack Medical Device Under Voluntary FDA Recall

    DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.

    Product
    DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0817-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2883-2020·2020-09-02

    GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue

    GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.

    Product
    CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0254-2020·2019-11-06

    Centurion Medical Products Recalls GRIPPER Needles in Illinois

    Centurion Medical Products Corporation is recalling GRIPPER Needles in Illinois. The recall was initiated by the supplier.

    Product
    Maintenance Flush Kit/Blood Draw Product Code: DT19335
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1334-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 2000 Medical Devices

    Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000 sterile, disposable, one-patient use devices due to a Class II classification.

    Product
    Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2018·2018-03-28

    Centurion Medical Recalls Latex Free IV Start Sets

    Centurion Medical Products Corporation is recalling Latex Free IV Start Sets due to a Class II FDA recall. The products were distributed nationally.

    Product
    LATEX FREE IV START SET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1092-2018·2018-03-28

    Centurion Medical Recalls Pediatric IV and IV Start Kits

    Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.

    Product
    PEDIATRIC IV & IV START KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1097-2018·2018-03-28

    Centurion Medical Products Recalls Wound Care Kits

    Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.

    Product
    WOUND CARE KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2336-2017·2017-06-21

    Arrow Multi-Lumen CVC Kit Recalled by FDA for Medical Device Safety

    Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.

    Product
    Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2017·2017-06-21

    Arrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access

    Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.

    Product
    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns

    ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
    Category
    Medical Device
    Distribution
    14 states