Hazard

Instruction Error recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2026-05-13

Of the 9 instruction 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 instruction 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.

1–9 of 9

ModerateFDA (Devices)·Z-2071-2026·2026-05-13
DEX Ophthalmic Tissue Forceps instructions for use correction
Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1248-2025·2025-03-05
Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2022·2022-07-27
Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical Device
Distribution
31 states
ModerateFDA (Devices)·Z-1110-2022·2022-05-25
Documentation errors recalled in HeartWare HVAD instructions and manuals
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
Product
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0467-2022·2022-01-19
Ki Mobility Little Wave Tyke Manual Contains Incorrect Instructions
The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.
Product
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by per
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0363-2022·2021-12-22
Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions
Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.
Product
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2543-2021·2021-10-06
Carotid and Gelsoft vascular patches recalled for incorrect instructions
Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2542-2021·2021-10-06
Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use
Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.
Product
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2174-2021·2021-08-11
AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
Product
Kaguya Automated Peritoneal Dialysis System
Category
Medical Device
Distribution
Distributed nationwide