FDA Medical Device Recalls (openFDA)
Myco Medical Supplies Inc: Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
- Recall number
- Z-0444-2016
- Recalling firm
- Myco Medical Supplies Inc
- Product
- Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
- Status
- Terminated
- Initiated
- 2015-11-06
- Posted
- 2015-12-17
- Terminated
- 2017-05-03
- Reason
- Particulates: Complaints of rubber coring from the closure of injection vials.
- Root cause
- Under Investigation by firm
- Action
- MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com or cal the Quality Department at 919-460-2535/ QA@mycomedical.com.
- Quantity
- 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
- Lot, serial or model codes
- Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.
- 510(k) numbers
- ["K945225"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1000158634
- Firm city
- Cary
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28