The Recall Desk

Hazard

Improper Fit recalls

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

What the numbers show

Total
36
Critical
0
Severe
5
Most recent
2025-06-25

Of the 36 improper fit recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (14%) 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 improper fit 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 36

  • HighFDA (Devices)·Z-1987-2025·2025-06-25

    Biomet 3i Certain-Compatible 4.1mm Milled Titanium Dental Abutments

    Preat Corp is recalling Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model 9001767-F) due to manufacturing defects that may cause improper screw engagement. The screw seat was positioned too high, potentially compromising the attachment of mating screws to the underlying implant.

    Product
    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2025·2025-03-12

    ET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers

    Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.

    Product
    ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1138-2025·2025-02-19

    Stryker Precision Thin Blade Attachments Recalled for Measurement Failure

    Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0743-2025·2025-01-01

    3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating

    3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.

    Product
    Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2024·2024-08-28

    Medline medical procedure kits recalled for dimensional variation

    Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2694-2024·2024-08-28

    Medline Soft Suction Canister Liner Recalled for Dimensional Variation

    Medline Industries recalls soft suction canister liners due to dimensional variation that may cause difficulty fitting the product into the outer canister. The issue affects units distributed worldwide.

    Product
    LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece

    The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.

    Product
    X-Guide Handpiece Adaptor Sleeve 1, Model P010701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall

    X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.

    Product
    X-Guide Handpiece Adaptor Sleeve 3, Model P010727
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2024·2024-03-27

    Dental Implant Impression Coping Recalled for Manufacturing Defect

    Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.

    Product
    impression coping, repositionable, short, screw-retained, PF 4.0
    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-0078-2023·2022-10-19

    Olympus VC-10 Vacuum Curettage System Recalled for Incompatible Accessories

    Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.

    Product
    Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2022·2022-04-20

    Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit

    The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2022·2022-02-16

    Avanos MIC Percutaneous Gastrostomy Kit Recalled for Bolster Sizing Defect

    Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy PEG Kit because the external retention bolster may be larger than the tube, creating a risk of improper fit and potential device failure.

    Product
    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2022·2022-01-12

    Medshape DYNANAIL MINI surgical nail recalled for improper endcap length

    Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.

    Product
    DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2198-2021·2021-08-11

    Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration

    Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.

    Product
    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues

    Biomet UK Ltd. is recalling 10 units of HipLOC Hip Fracture Fixation System plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2018·2018-08-01

    DePuy CORAIL Femoral Stems Recalled Due to Incorrect Size Labeling

    DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.

    Product
    CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1240-2018·2018-04-04

    Zimmer Biomet Recalls Persona Partial Knee Spacer Blocks

    Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks because they may feel tight during trialing or appear loose in extension.

    Product
    Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2017·2017-02-15

    Vertebral Technologies Recalls InterFuse Tail Traction Tool Due to Fit Issues

    Vertebral Technologies is recalling 63 InterFuse Tail Traction Tools because they may not fit properly with the InterFuse T implant.

    Product
    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow th
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1778-2014·2014-06-18

    Stryker Precision Neuro Drill Recall Due to Missing Notches

    Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1750-2014·2014-06-18

    Stryker Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 72 sterile 1.0mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications in
    Category
    Medical Device
    Distribution
    Distributed nationwide