ClearanceBrief
Recall Z-1765-2025 ยท GAD Retractor

MEDLINE INDUSTRIES, LP - Northfield

Centurion Sterile Weitlaner Retractor, Reorder: 67315

DateMay 15, 2025 (initiated Apr 9, 2025)
StatusOpen, Classified
ReasonThree is the potential for the retractors to puncture through the sterile packaging.
Root causeUnder Investigation by firm
ActionMedline issued a MEDLINE DEVICE RECALL notice to its consignees on 04/09/2025, The notice explained the issue, potential risk, and requested the following: REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affec
Quantity2100 units
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.