Device recalls

Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Ite…

AVID Medical, Inc. · The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Mo…

Open, ClassifiedMaterial/Component ContaminationZ-3046-2026
Open FDA's page for this record
Cfres ID
221622
Product res number
Z-3046-2026
Event date initiated
2026-05-19
Event date posted
2026-08-28
Recall status
Open, Classified
Res event number
99469
Product code
OJH
Firm FEI number
1047429
Recalling firm
AVID Medical, Inc.
Address 1
9000 Westmont Dr
City
Toano
State
VA
Postal code
23168-9351
Additional info contact
Marlene Jones 470-280-4277
Root cause description
Material/Component Contamination
Product quantity
816 kits
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.
Product description

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.

Code info

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.

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.

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."

Harmonized identifiers (openFDA)
Device name
Orthopedic Tray
Medical specialty description
General, Plastic Surgery
Regulation number
878.4800
Device class
1
Registration number
3017307654, 3008395366, 3007663067, 1417592, 3015543569, 1424263, 3015131017, 3008534770, 3004911384, 3010667733, 1043534, 3009203853, 3012120772, 3008111820, 3013552417, 3018077422, 3006981798, 3004111573, 9616088, 9710629, 1030451, 1047429, 3014170143, 1423395, 3017823294, 1221053, 2029015, 3004122598, 1020279, 8044102, 1423537, 3011187779, 1643817, 3003477135, 3007329020, 1923569, 3008864603, 1061124, 1450662, 3014554088 +19 more
FEI number
3017307654, 3008395366, 3007663067, 1417592, 3015543569, 3002902735, 3015131017, 3003407235, 3008534770, 3004911384, 3010667733, 1043534, 3009203853, 3012120772, 3008111820, 3013552417, 3018077422, 3003015552, 3006981798, 3004111573, 1030451, 3000717925, 1047429, 3014170143, 1221053, 3017823294, 1020279, 3004122598, 1000123180, 3011187779, 3000717687, 1643817, 3003477135, 3007329020, 1923569, 3008864603, 1450662, 3014554088, 3014680744, 1928237 +19 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.