FDA Medical devices recall ·
HemosIL SynthAFax recall
- Recall number
- Z-0938-2026
- Date
- (initiated November 18, 2025)
- Company / brand
- Instrumentation Laboratory
180 Hartwell Rd, Bedford, MA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 4,506 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Why was it recalled?
Recalled lots were manufactured with double the amount of preservative concentration.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Distribution
Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.
States: Arkansas California Colorado Delaware Florida Illinois Indiana New York
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0938-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.