FDAClass II · Medical device · Recall Z-0096-2027 · Recalled October 14, 2026

CRANIOTOMY PACK recall — AVID Medical, Inc.

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: CRANIOTOMY PACK
Company / brand: AVID Medical
Lot / serial / date codes: 1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;
Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Agency product description and boundaries

CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Product may be potentially contaminated with a lubricant used during the manufacturing process.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: CRANIOTOMY PACK recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-0096-2027
Brand: All AVID Medical recalls
Classification: Class II
Units affected: 10
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

CRANIOTOMY PACK recall status

Companies & origin

Recalling firm location: Toano, VA, United States
Firm address: 9000 Westmont Dr, N/A, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots: 1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;
Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Firm notified the public via: E-Mail
FDA event ID: 99808
Recall initiated: August 10, 2026
FDA classified: October 7, 2026
FDA report date: October 14, 2026

More AVID Medical recalls

Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard 18G SINGLE SHOT EPI TRAY recall — AVID Medical, Inc.FDA · September 23, 2026

Other medical device recalls from around the same time

VentStar Resus Neo recall — Draeger, Inc.FDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LPFDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LPFDA · October 7, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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