CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
SQ40S Blood Transfusion Filter recalled by GVS TM
GVS TM is recalling SQ40S Blood Transfusion Filter, distributed in 28 states. The recall was initiated on 3 Nov 2025 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-1157-2026
- FDA event ID
- 98145
- Recalling firm
- GVS TM, Covina, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Nov 2025
- FDA classified
- 22 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2025 | Recall initiated by company | |
| 22 Jan 2026 | Classified by FDA | +80 days |
| 28 Jan 2026 | Published 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
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
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
SQ40S Blood Transfusion Filter
Where it was distributed
U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA
AlabamaArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraskaNevada
Questions about this recall
Why was it recalled?
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Which lots are affected?
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Where was it sold?
U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA
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.
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