Hazard

Incorrect Sizing 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: 2025-05-28

Of the 10 incorrect sizing 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 incorrect sizing 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

ModerateFDA (Devices)·Z-1786-2025·2025-05-28
Check-Flo Performer Introducer medical device recall for incorrect sheath sizing
Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.
Product
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2024·2024-05-29
Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
Product
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2023·2023-06-14
TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0096-2023·2022-10-26
Laryngeal mask airway recalled for incorrect size marking
Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.
Product
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1453-2022·2022-08-03
NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information
NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.
Product
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1261-2022·2022-06-22
FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling
Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.
Product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0746-2019·2019-01-23
DeRoyal Enteral Safe Feed Tube Recall Due to Incorrect Sizing
DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.
Product
DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1462-2018·2018-05-02
Howmedica Triathlon Revision Knee Implants Recalled for Sizing Errors
Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.
Product
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1487-2017·2017-03-29
Crossroads MotoCLIP Super Elastic Fusion System Recalled for Incorrect Sizing
Crossroads Extremity Systems is recalling 20 units of MotoCLIP Super Elastic Fusion Systems because seven implants were incorrectly sized and labeled.
Product
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1824-2015·2015-07-01
CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging
CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.
Product
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Category
Medical Device
Distribution
Distributed nationwide