Hazard

Sizing Error recalls

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

What the numbers show

Total: 10
Critical: 0
Severe: 0
Most recent: 2024-01-24

Of the 10 sizing error 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 sizing error 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.

1–10 of 10

HighFDA (Devices)·Z-0749-2024·2024-01-24
Link Patella Glide Resection Guide recalled due to size mislabeling
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
Product
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2405-2023·2023-08-23
Hip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm
Conformis hip screws measuring 30mm have been mislabeled as 25mm, creating risk of incorrect surgical implantation. The recall affects 25 units distributed across nine states.
Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1921-2023·2023-06-21
Exeter V40 Trial Head 26mm -3 Color Mislabeling
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
Product
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1407-2023·2023-04-26
Surgical Centurion CirClamp Recalled for Incorrect Subassembly Size
Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.
Product
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1020-2023·2023-02-01
AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
Product
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2023·2022-12-28
Corin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
Product
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2238-2021·2021-08-18
Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size
Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1993-2021·2021-07-07
Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling
One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.
Product
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1192-2018·2018-04-04
Zimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error
Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.
Product
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2309-2012·2012-09-12
Cook Ireland Recalls Zilver Vascular Stents Due to Sizing Error
Cook Ireland is recalling 15 Zilver 518 Vascular Self Expanding Stents because a unit was found to be the wrong size, causing it to lodge in a sheath.
Product
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. P
Category
Medical Device
Distribution
Distributed nationwide