BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to…
Medical device recall Z-0609-2018. Published in FDA’s Enforcement Report on Feb 21, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 29 states named in where it went
- 1863 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Cut resistant surgical glove liners lack sterility assurance.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
1863, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item Number Lot Number Expiration Date: 1. 650126 326624 9/30/2017; 2. 650126 330363 11/30/2017; 3. 650128 330363 12/1/2017; 4. 650129 330363 12/1/2017; 5. 650129 351411 6/28/2018; 6. 650127 353495 7/28/2018; 7. 650128 353498 7/28/2018; 8.…
Every code shown here, 1,258 characters
Item Number Lot Number Expiration Date: 1. 650126 326624 9/30/2017; 2. 650126 330363 11/30/2017; 3. 650128 330363 12/1/2017; 4. 650129 330363 12/1/2017; 5. 650129 351411 6/28/2018; 6. 650127 353495 7/28/2018; 7. 650128 353498 7/28/2018; 8. 650131 353504 7/28/2018; 9. 650129 357204 7/28/2018; 10. 650128 361436 8/28/2018; 11. 650129 361467 8/28/2018; 12. 650128 000011 11/28/2018; 13. 650128 231984 12/22/2018; 14. 650129 000011 2/28/2019; 15. 650128 379203 2/28/2019; 16. 650131 390179 6/28/2019; 17. 650131 395315 8/28/2019; 18. 650128 259231 9/30/2019; 19. 650127 401155 10/28/2019; 20. 650130 402602 10/28/2019; 21. 650127 402602 11/28/2019; 22. 650131 402602 11/28/2019; 23. 650128 393754 12/28/2019; 24. 650129 402602 1/28/2020; 25. 650130 417501 9/28/2020; 26. 650128 437240 11/28/2020; 27. 650127 437240 12/28/2020; 28. 650130 437240 12/28/2020; 29. 650129 437240 1/28/2021; 30. 650128 444717 4/28/2021; 31. 650129 444717 4/28/2021; 32. 650131 457763 4/28/2021; 33. 650128 457130 6/28/2021; 34. 650130 457130 6/28/2021; 35. 650129 457130 8/28/2021; 36. 650130 476615 1/28/2022; 37. 650130 486487 3/28/2022; 38. 650129 486488 3/28/2022; 39. 650130 482368 4/28/2022; 40. 650127 482370 4/28/2022; 41. 650129 482370 4/28/2022; 42. 650130 343401 4/30/2018
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran’s Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.
The states and territories these words name
29 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- Montana
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- West Virginia
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 11, 2017.
- FDA classified it on Feb 14, 2018.
- FDA’s Enforcement Report published it on Feb 21, 2018.
- FDA terminated it on Aug 30, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.