Teleflex recalls D-Stat Flowable Hemostat (REF 4000) with expired diluent vials that may compromise sterility. Affected units have specific lot numbers and expiration dates. Consumers should check their product details.
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
“Teleflex D-Stat Flowable Hemostat Recall: Expired Diluent Vial Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58581-teleflex-d-stat-flowable-hemostat-recall-expired-diluent-vial-risk. Based on FDA recall #Z-1611-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1611-2023%22&limit=1).
The FDA announced on April 12, 2023, that Teleflex LLC is recalling D-Stat Flowable Hemostat products due to expired diluent vials. This defect means the sterility of the diluent component cannot be assured. The recall affects 1,140 units distributed nationwide.
Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
The hazard
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
Context
GovInfoNow's records show Teleflex LLC has 8 other recalls on record since August 29, 2022. Other recent recalls include a May 7, 2026 recall for Pilling Wecksorb Neurosponges due to endotoxin risk and a May 25, 2023 recall for Teleflex Preformed AGT Oral Endotracheal Tubes involving connector disconnection risks. Similar recent recalls include April 21, 2026 recalls for Medtronic DLP Cannula and Retrograde Cannula products due to sterile barrier breach risk and a March 5, 2026 recall for Cook Medical Multipurpose Drainage Catheters where expiration dates exceed shelf life.
How to tell if you have this one
Check for the product name 'D-Stat Flowable Hemostat', reference number REF 4000, and lot numbers 717535 (exp. 04/27/2023) or 717413 (exp. 04/25/2023).
Brand
Teleflex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the product label to confirm if it matches the affected units.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Is there a risk of serious injury from this product?
The recall is for potential infection risks due to expired diluent, not direct injury. The hazard does not involve immediate risks like fire or laceration.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1611-2023 (April 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1611-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.