CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
Ritmed Neurological Sponges, Description recalled by AMD Medicom
AMD Medicom is recalling Ritmed Neurological Sponges, Description, distributed in 9 states. The recall was initiated on 8 May 2026 and the FDA has classified it as Class II.
Check your package
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-2458-2026
- FDA event ID
- 99006
- Recalling firm
- AMD Medicom, Montreal
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2026
- FDA classified
- 16 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 May 2026 | Recall initiated by company | |
| 16 Jun 2026 | Classified by FDA | +39 days |
| 24 Jun 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
CaliforniaIllinoisMontanaNorth CarolinaOhioRhode IslandTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
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 99006| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ritmed Neurological Sponges, Sterile recalled by AMD Medicom | AMD Medicom | Device Malfunction | 9 states |
More recalls from AMD Medicom
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ritmed Neurological Sponges, Sterile recalled by AMD Medicom | AMD Medicom | Device Malfunction | 9 states |
| Device | CLASS II | Henry Schein¿ Criterion¿ Anti-fog Earloop Masks Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
| Device | CLASS II | Henry Schein¿ Criterion¿ Earloop Masks Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
| Device | CLASS II | Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
| Device | CLASS II | Medicom Safemask Premier Plus Astm Level 3 Masks recalled by AMD Medicom | AMD Medicom | Packaging Defects | 13 states |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |