The Recall Desk

Hazard

Wrong Size recalls

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

What the numbers show

Total
22
Critical
0
Severe
0
Most recent
2026-06-24

Of the 22 wrong 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 0 (0%) 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 wrong 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.

1–22 of 22

  • HighFDA (Devices)·Z-2461-2026·2026-06-24

    Stryker Triathlon size 3 baseplate packaging contained a size 4 implant

    Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2026·2026-06-24

    Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

    Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1550-2026·2026-03-18

    Medartis APTUS TriLock screw lots mixed 2.5 mm and 2.8 mm

    Medartis is recalling one lot of the APTUS 2.8 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2026·2026-03-18

    Medartis APTUS 2.5 TriLock screw lots mixed with 2.8 mm

    Medartis is recalling one lot of the APTUS 2.5 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2026·2025-12-17

    Ureteral stent kits, 4.7 French, recalled over a size labeling discrepancy

    C.R. Bard is recalling 4,350 BD InLay Optima Ureteral Stent Kits, 4.7 Fr x 26 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0908-2026·2025-12-17

    Ureteral stent kits, 8 French, recalled over a size labeling discrepancy

    C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 8 Fr x 26 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2026·2025-12-17

    Ureteral stent kits recalled because the stent size may not match the label

    C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 6 Fr x 30 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0905-2026·2025-12-17

    Short ureteral stent kits recalled over a size labeling discrepancy

    C.R. Bard is recalling 116 Bard InLay Optima Ureteral Stent Kits, 6 Fr x 14 cm, because the actual stent size may not match the product label.

    Product
    Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2026·2025-10-29

    Forty six millimetre locking screws recalled over wrong length on packaging

    Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2026·2025-10-29

    Locking bone screws recalled after packaging labeled with the wrong length

    Synthes is recalling 122 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2025·2025-09-17

    Introducer sheath systems recalled over pouch labels showing the wrong size

    Fortress Introducer Sheath Systems, 6F straight 45 cm, lot 800989, are recalled because units may carry a pouch label listing the reference number and UDI of the 4F version. 2,500 units are affected.

    Product
    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2025·2025-01-22

    Esteem Synergy Stomahesive Skin Barrier pre-cut wafers wrong size

    ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.

    Product
    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2023·2022-10-12

    Orthopedic implant recall due to labeling mismatch on Stryker EVOLVE Proline Stem

    Wright Medical Technology recalls 32 units of Stryker EVOLVE Proline Stem due to labeling mismatch: outer packages are labeled with one stem size but contain a different size. Surgeons should verify device size before implantation.

    Product
    stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2022·2022-06-29

    INTERGARD Woven Vascular Graft mislabeled with incorrect size specification

    Maquet Cardiovascular recalls INTERGARD Woven Vascular Grafts with incorrect labeling. Units labeled as 8 mm diameter instead contained 32 mm diameter grafts.

    Product
    INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic gr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2658-2017·2017-07-12

    Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-packaging Error

    Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.

    Product
    3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2747-2016·2016-09-14

    Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up

    Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.

    Product
    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide