Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.
FDA Recall Z-3046-2026 · Posted 2026-08-28
Advertisement
Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2026-05-19
Product Quantity816 kits
Reason for Recall
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Firm Action
Owens & Minor issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION to its consignees on 5/19/2026 via email. The notice explained the issue, potential risk to health and requested the following:
"ACTIONS TO TAKE:
" Identify, segregate, and quarantine all impacted product.
" Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.
" Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.
" Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness."
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement