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AVID Medical Halyard Convenience Kits Recall Over Endotoxin Variability in Neurological Sponges

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

AVID Medical, Inc. is recalling 816 Halyard medical convenience kits nationwide due to potential unexpected variability of endotoxin levels in included Ritmed Neurological Sponges.

FDA recall: what the record actually shows

This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

AVID Medical, Inc. initiated a voluntary recall of certain Halyard medical convenience kits after receiving notification of a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential for unexpected variability of endotoxin levels on the products.

Which Products Are Affected

The recall covers 816 kits distributed nationwide in AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, and GA. Affected products include:

  • A-P PACK - 205936, Model/Item Number (kit) ANAP22-01 (UDI/DI 10809160473146), lots 346967, 346982
  • POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01 (UDI/DI 10809160473573), lots 343413, 343414, 343713, 343715, 343716, 343412, 343416, 343714, 343717, 343718, 343719, 343723
  • ANEURYSM PACK, Model/Item Number (kit) BPAY14-01 (UDI/DI 10809160473979), lots 343746, 343747, 343771, 374128, 374129, 374296
  • SPINE PACK, Model/Item Number (kit) HSLM53-01 (UDI/DI 10809160476888), lots 342005, 344071, 347906, 341835, 343206, 343208
  • ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01 (UDI/DI 10809160479537), lot 345289
  • SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01 (UDI/DI 10809160479797), lots 345694, 341654
  • CRANI PACK, Model/Item Number (kit) WECR41-01 (UDI/DI 10809160485392), lot 344464

Recall number Z-3046-2026. Classification: Class II. Status: Ongoing.

What You Should Do

Consumers should verify lot numbers against the recalled list provided by the firm.

Why This Matters

This Class II recall addresses a potential risk of adverse health consequences from variable endotoxin levels in the affected kits distributed across the United States.

Source

FDA recall number Z-3046-2026, AVID Medical, Inc., Toano, VA.

Original source: FDA Official Notice ↗

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Comparable nationwide notices (length or severity timing) 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Similar body length

Nearest notices by article body length (1,810 characters here).

Severe Thunderstorm Warning for Heavy Rainfall in Kimberley, North Interior and Pilbara Districts 1,810 chars Goal Zero Recalls YETI 3000X Power Stations 1,810 chars Blowing Dust and High Wind Warning Issued for Southeast Colorado Through Tuesday Evening 1,810 chars Red Flag Warning Issued for Northeast and Central New Mexico Through Sunday 1,810 chars

Similar severity timing

Same severity (medium) notices issued closest in time to September 14, 2026.

Freeze Warning for Star Valley (Sep 14, 2026) medium M 5.3 Earthquake off the Coast of Michoacan, Mexico medium M 5.2 Earthquake 135 km SE of Gizo, Solomon Islands medium M 5.6 Earthquake 78 km NNE of Tobelo, Indonesia medium

What People Ask

Common questions about this FDA recall.

What is this FDA recall about? ▾
AVID Medical, Inc. is recalling 816 Halyard medical convenience kits nationwide due to potential unexpected variability of endotoxin levels in included Ritmed Neurological Sponges.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter? ▾
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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