The Recall Desk

Hazard

Incorrect Size recalls

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

What the numbers show

Total
32
Critical
0
Severe
3
Most recent
2024-09-04

Of the 32 incorrect size recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (9%) 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 incorrect size 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 32

  • ModerateFDA (Devices)·Z-2719-2024·2024-09-04

    Cobra EMG ET Tube Recalled Due to Incorrect Size Labeling

    Neurovision Medical Products recalls Cobra 3-Plate EMG ET Tubes due to mislabeling with incorrect tube size on the label. The error could affect proper product selection in clinical procedures.

    Product
    Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2024·2024-08-21

    PICC Catheter Package Contains Wrong Length, Causing Procedural Delay

    Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.

    Product
    L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2024·2024-01-10

    Spinal fixation screws recalled due to incorrect size laser marking

    Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.

    Product
    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1184-2021·2021-03-17

    MedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size

    Medical Components, Inc. is recalling 96 Power Injectable CT Port kits because they contain 6.6F ports instead of the correct 5F size, which may prolong surgical procedures.

    Product
    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2020·2020-02-12

    Wright Medical Recalls EVOLVE Modular Radial Head Due to Sizing Errors

    Wright Medical Technology is recalling 39 EVOLVE Modular Radial Heads because the product size inside the package does not match the label or laser marking.

    Product
    WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1102-2020·2020-02-12

    Wright Medical Recalls EVOLVE Modular Radial Heads Due to Sizing Errors

    Wright Medical Technology is recalling two lots of EVOLVE Modular Radial Heads because the product size in the package may be incorrect. Both labels and laser markings are wrong.

    Product
    WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0789-2020·2020-01-15

    Abbott Recalls Fast-Cath Hemostasis Introducers Due to Incorrect Size

    Abbott Medical is recalling 380 Fast-Cath Hemostasis Introducers because three lots contained 8F components instead of the labeled 8.5F size.

    Product
    Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2020·2020-01-15

    Abbott Fast-Cath Trio Hemostasis Introducer Recalled for Incorrect Size

    Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices because they contain 12F components instead of the expected 14F size.

    Product
    Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2019·2019-04-10

    Zimmer Biomet Recalls RingLoc Hip System Self-Tapping Bone Screws

    Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.

    Product
    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2018·2018-07-04

    Zimmer Biomet Recalls Vanguard Knee Bearings Due to Packaging Mix-up

    Zimmer Biomet is recalling 48 Vanguard Complete Knee System tibial bearings because two lots were commingled, creating a risk that 14mm bearings are packaged in 12mm boxes or vice versa.

    Product
    Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2017·2017-04-26

    Verathon Recalls GVL 2 Stat Blades Packaged with Incorrect Size

    Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.

    Product
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part nu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2017·2017-02-15

    Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency

    Teleflex Medical is recalling Sheridan cuffed tracheal tubes because some units are labeled with incorrect sizes, potentially leading to improper airway management.

    Product
    Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2211-2016·2016-07-20

    Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging

    Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.

    Product
    Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number a
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1667-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1668-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling 27 Otologic Curved Micro Diamond Ball Burrs because they may be missing the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1174-2016·2016-03-23

    Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size

    Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.

    Product
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2016·2016-03-23

    Collagen Matrix Recalls NuOSS Cancellous Dental Product Due to Size Error

    Collagen Matrix Inc is recalling 171 units of NuOSS Cancellous dental product shipped to Massachusetts because some units may have the incorrect size.

    Product
    NuOSS Cancellous Intended for use in dental surgery.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1054-2016·2016-03-16

    CooperSurgical Recalls Milex Arcing Diaphragms Due to Incorrect Size

    CooperSurgical, Inc. is recalling two units of Milex Arcing Diaphragms (Model MXWS95) because they contain an incorrect size diaphragm.

    Product
    Milex Arcing Diaphragm Size 95; Model Number: MXWS95
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0595-2016·2016-01-13

    Benlan Pediatric Feeding Tubes Recalled for Incorrect Size Packaging

    Benlan, Inc. is recalling specific lots of 8 FR pediatric feeding tubes that may be packaged with 5 or 6.5 FR tubes instead.

    Product
    MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1404-2015·2015-04-15

    Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems

    Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.

    Product
    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0579-2014·2014-01-01

    OrthoPediatrics ACL Sleeve Installation Tool Recall for Incorrect Size Etching

    OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.

    Product
    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surger
    Category
    Medical Device
    Distribution
    Distributed nationwide