Healthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
Healthmark Industries is recalling 12.8 million vinyl instrument guards because their labeling does not comply with FDA regulations and steam sterilization instructions have been updated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to labeling non-compliance with 21 CFR 801 and updated steam sterilization instructions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Healthmark Industries Co., Inc. is recalling approximately 12,835,920 units of Vinyl Instrument Guards. The recall involves multiple model numbers, including 09-1-011, 09-1-012, 09-1-013, 09-1-014, 09-1-015, 09-1-016, 09-1-017, 09-1-018, 09-1-019, 09-1-020, and 09-2-011, in various colors and sizes. The products were distributed worldwide, including in the United States, Japan, Australia, Canada, and numerous other countries.
The recall was initiated because the product labeling is not compliant with 21 CFR 801. Additionally, the instructions for use (IFU) regarding steam sterilization have been updated. The source text does not report any illnesses, injuries, or deaths associated with the use of these products.
Healthcare facilities and consumers who have these specific model numbers should check their inventory against the list of affected lot numbers and model numbers provided in the official recall notice. Users should stop using the affected products and contact Healthmark Industries for further instructions on replacement or return.
The recalled product
- Product
- Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD…
- Manufacturer
- Healthmark Industries Co., Inc.
- Affected units
- 12,835,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number 09-1-011
- UDI DI 00840113213610
- Lot Number 46313
- Lot Number 48704
- Lot Number 52563
- Lot Number 54316
- Lot Number 56859
- Lot Number 62805
- Lot Number 66222
- Lot Number 68451
- Lot Number 70818
- Lot Number 76638
- Lot Number 77955
- Lot Number 85979
- Lot Number 88504
- Lot Number 091011
- Lot Number 92954
- Lot Number 93535
- Lot Number 95456
- Lot Number 96593
Distribution
Distributed nationwide across the United States.
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