The Recall Desk

Hazard

Component Mismatch recalls

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

What the numbers show

Total
38
Critical
0
Severe
0
Most recent
2025-12-10

Of the 38 component mismatch recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all component mismatch 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 38

  • HighFDA (Devices)·Z-0417-2026·2025-11-12

    Dental implant screws recalled because the wrong screw was packaged

    Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.

    Product
    Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0419-2026·2025-11-12

    Size G hip bearings recalled over commingled implant sizes in packaging

    Zimmer is recalling 63 Dual Mobility Vivacit-E bearings labelled Size G 46 mm because the package contents and label may be commingled with the Size F 44 mm bearing.

    Product
    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0418-2026·2025-11-12

    Hip bearings recalled because size F packages contain size G implants

    Zimmer is recalling 72 Dual Mobility Vivacit-E bearings labelled Size F 44 mm because the implant inside the package is a Size G 46 mm, and the reverse also occurred.

    Product
    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0113-2025·2024-12-18

    Varithena Administration Pack Recalled Due to Incorrect Syringe Connector Type

    Biocompatibles is recalling 432 Varithena (polidocanol injectable foam) Administration Packs due to incorrect syringe connectors. The packs contain luer lock syringes instead of the required luer slip connection syringes.

    Product
    Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0223-2025·2024-10-30

    A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes

    Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.

    Product
    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2024·2024-05-29

    FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch

    Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.

    Product
    Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2024·2024-03-13

    ConvaTec Natura Stomahesive surgical ostomy system pouch-flange coupling mismatch

    ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.

    Product
    ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1149-2024·2024-02-28

    PERIFIX epidural kits recalled for incompatible filter straw connectors

    B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2024·2023-12-27

    Orthopedic implant head recall due to incorrect adapter in packaging

    Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0469-2023·2022-12-21

    Zimmer NexGen Option Stemmed Tibial Component Voluntary Recall Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to clinically significant higher revision rates when used with specific femoral components. Patients should contact their surgeon to discuss their implant.

    Product
    NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2022·2022-06-15

    GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall

    Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.

    Product
    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0842-2022·2022-04-06

    Ceramic Hip Femoral Head Component May Not Match Package Label

    Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.

    Product
    Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2022·2021-10-13

    Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up

    Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.

    Product
    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2022·2021-10-13

    ATTUNE Revision Tibial Augment recalled for packaging with incompatible screws

    ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.

    Product
    ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2021·2021-07-07

    PowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components

    Bard Access Systems is recalling 180 units of 5Fr PowerPICC Catheter kits because they contain incorrect micro-introducers.

    Product
    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1976-2021·2021-07-07

    Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly

    Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.

    Product
    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2021·2021-06-09

    Zimmer Natural Nail cephalomedullary device angle mismatch recall

    Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.

    Product
    Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1964-2020·2020-05-20

    Bard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size

    Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.

    Product
    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2020·2020-04-08

    Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up

    Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.

    Product
    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
    Category
    Medical Device
    Distribution
    18 states
  • LowFDA (Devices)·Z-1326-2020·2020-02-26

    Theralase Inc. Recalls TLC-2000 Therapeutic Medical Laser Systems

    Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.

    Product
    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2020·2020-02-19

    Cardiac Assist Recalls TandemLife ECLS Procedure Kits with Incorrect Cannula

    Cardiac Assist, Inc. is recalling 11 TandemLife ECLS Procedure Kits that contained a 29Fr ProtekDuo cannula instead of the intended 24Fr Protek Solo Venous cannula.

    Product
    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2018·2018-03-07

    Alcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch

    Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states