CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report

medical procedure kits and trays labeled as recalled

American Contract Systems is recalling medical procedure kits and trays labeled as: Anterior Cervical Pack - 205988, distributed in Iowa, Minnesota, Missouri. The recall was initiated on 19 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.
Quantity recalled160 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2990-2026
FDA event ID
99482
Recalling firm
American Contract Systems, Tiffin, OH
Classification
Class II
Status
Ongoing
Recall initiated
19 May 2026
FDA classified
20 Aug 2026
Reported
26 Aug 2026
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Sterility
Device type
Spinal Implants

Timeline

19 May 2026Recall initiated by company
20 Aug 2026Classified by FDA+93 days
26 Aug 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.

Where it was distributed

US distribution to states of: MN, MO, IA

IowaMinnesotaMissouri

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.

Where was it sold?

US distribution to states of: MN, MO, IA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99482
ReportedClassRecallCompanyReasonWhere
CLASS IImedical procedure kits and trays labeled as: Crani Pack recalledAmerican Contract SystemsSterilityIA, MN, MO

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