| | Class 2 Device Recall Halyard |  |
| Date Initiated by Firm | May 19, 2026 |
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| Date Posted | August 28, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3046-2026 |
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| Recall Event ID |
99469 |
| Product Classification |
Orthopedic tray - Product Code OJH
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| Product | 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. |
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| Code Information |
Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346967;
Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346982;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343413;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343414;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343713;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343715;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343716;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343412;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343416;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343714;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343717;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343718;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343719;
Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343723;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343746;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343747;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343771;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374128;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374129;
Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374296;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 342005;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 344071;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 347906;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 341835;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343206;
Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343208;
Model/Item Number (kit) MHAC65-01, UDI/DI 10809160479537, Kit Lot Number 345289;
Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 345694;
Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 341654;
Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 344464.
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| FEI Number |
1047429
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Recalling Firm/
Manufacturer |
AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
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| For Additional Information Contact | Marlene Jones
470-280-4277 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| 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." |
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| Quantity in Commerce | 816 kits |
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| Distribution | 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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