The Recall Desk

Hazard

Size Mismatch recalls

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

What the numbers show

Total
23
Critical
0
Severe
1
Most recent
2025-06-04

Of the 23 size 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 1 (4%) 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 size 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.

1–23 of 23

  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2025·2025-06-04

    GM Helix Acqua Implant dental implant size misidentification recall

    Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2025·2025-04-09

    Cordis Vascular Stent System Recalled Due to Incorrect Product Size

    Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.

    Product
    Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0278-2025·2024-11-06

    Knee Prosthesis Implant Recall: Wrong Size Component Shipped

    Smith & Nephew is recalling a knee prosthesis component because packages were found to contain the wrong size implant. The size 3 left component was shipped instead of the size 4 left as labeled.

    Product
    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2370-2024·2024-07-24

    UNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch

    Howmedica Osteonics is recalling UNITRAX hip implant head components because the package label size may not match the device actually inside, potentially leading to incorrect surgical implantation. Affected units were distributed worldwide.

    Product
    UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2024·2024-07-10

    MicroPort Knee Implant Recall: Wrong Size Component in Packaging

    MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.

    Product
    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1901-2024·2024-06-05

    Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch

    Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.

    Product
    smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0213-2024·2023-11-08

    Orthopedic knee implant components mislabeled; size mix-up risk

    Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.

    Product
    Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2649-2023·2023-10-11

    Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly

    Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.

    Product
    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2023·2023-07-05

    Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error

    Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2023·2023-02-08

    Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side

    Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0465-2023·2022-12-14

    Arthrex Small Joint OATS Sets recalled for incorrect reamer size packaging

    Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.

    Product
    Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1383-2022·2022-07-20

    Aesculap Micro Needleholder Recalled for Incorrect Size Labeling

    Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.

    Product
    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1237-2022·2022-06-15

    Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch

    Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.

    Product
    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2022·2022-06-01

    Protekt Sharps Safety Knives with Incorrect Size Label

    International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.

    Product
    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle La
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2022·2022-04-06

    Hip prosthetic femoral head component size and offset labeling mismatch

    Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.

    Product
    Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2022·2021-11-10

    Dental implant recalled due to size mismatch with labeling

    Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.

    Product
    ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2022·2021-11-10

    Dental implants recalled for size mismatch with package labeling

    Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.

    Product
    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2022·2021-10-13

    Paltop Scan Abutment MU devices recalled for manufacturing tolerance deviations

    Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.

    Product
    Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2021·2021-09-08

    Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling

    Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.

    Product
    STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2014·2014-03-19

    Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch

    Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.

    Product
    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring
    Category
    Medical Device
    Distribution
    1 state