Device recall: Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE…
Class II FDA enforcement event 99943. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Class II, in the words of FDA
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
Healthmark Industries Co., Inc. started this device recall on 7 Sep 2026. The firm address in the FDA record is in Fraser, MI. FDA put the recall in Class II. FDA event 99943 has 1 product record. The first FDA enforcement report date is 21 Oct 2026. The record gives the status Ongoing. 278 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED…
Recalling firm
Healthmark Industries Co., Inc., Fraser, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0188-2027 | 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 5/64 X 3/4, Model Number 09-1-012; 5)… | 12,835,920 units | Class II | Ongoing | 21 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 677
- Share of these events in Class II
- 87%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2026 | healthmark ProChek-II, Model Number PT-313, PT-201-12 | Device | Class II | 2 |
| 12 Mar 2026 | Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style | Device | Class II | 1 |
| 2 May 2025 | Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0188-2027The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 99943. https://recallregister.com/fda/ii/99943/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED…
- What quantity of product is in FDA event 99943?
- The FDA record gives this quantity:
12,835,920 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 677 device events that started in 2026 are in Class II.