Z-2458-2026Class II

Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C...

Name: Z-2458-2026 Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C...
Creator: AMD Medicom Inc.
Published: 2026-05-08
License: https://open.fda.gov/license/

AMD Medicom Inc. / initiated 2026-05-08 / Open, Classified / root cause: manufacturing process

FDA source

AMD Medicom Inc. began a recall of Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in... on 2026-05-08. FDA classified it as Class II and gives the reason as "Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2458-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-08
Posted: 2026-06-16
Recalling firm: AMD Medicom Inc.
Product: Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
Product code: EFQ Gauze/Sponge, Internal
Reason for recall: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 5/8/2026, recall notices were emailed to customers who were asked to do the following: 1) Discontinue use, quarantine and destroy affected devices. 2) Notify any customers or facilities to whom you have distributed this product. 3) Complete and return the response form via email to firm's customer service at [email protected] On 6/5/2026, recall notices with all affected lots were emailed to customers.
Quantity in commerce: 7,838,200
Distribution: US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Product codes and lots: UDI-DI: 20686864043205. Distributed After May 1st, 2022, including the following lots: 19316, 16409, 15463-7, 15463-6, 15463-5, 15463-4, 15463-3, 15463-2, 15463-1, 15463, 15192-1, 15192, 14813, 14039, 13673, 13289, 12641, 12206, 11851, 11020-1, 11020, 10586, 10392, 9243, 8160, 7784, 7748, 7044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2458-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2458-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-16
Z-2459-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-16

Product code EFQ

K830269UnclassifiedFloret Neuro SpongeRitmed, Inc. / cleared 1983-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)