Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
Vinyl Instrument Guards, labeled as
Healthmark Industries Co., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Healthmark Industries Co., Inc. · 18600 Malyn Blvd · Fraser, MI · 48026-3496
Is this the product you have?
496 of 496 products
| Model / number | Barcodes | Product as published |
|---|---|---|
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 46313 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 48704 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 52563 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 54316 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 56859 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 62805 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 66222 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 68451 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 70818 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 76638 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 77955 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 85979 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 88504 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 091011 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 92954 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 93535 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 95456 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 96593 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 99366 |
09-1-011 | 00840113213610 | UDI DI 00840113213610, Lot Number 103829 |
- Amount recalled
- 12,835,920 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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