FDAClass II · Medical device · Recall Z-3147-2026 · Recalled September 23, 2026

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall — Bayer Medical Care, Inc.

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
Company / brand: Bayer Medical Care
Lot / serial / date codes: Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Distribution: US Nationwide distribution.

Agency product description and boundaries

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3147-2026
Brand: All Bayer Medical Care recalls
Classification: Class II
Units affected: 27800 kits (556 boxes)
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall status

Companies & origin

Recalling firm location: Indianola, PA, United States
Firm address: 1 Bayer Dr, N/A, 15051-9702

Identifying details (verbatim from the notice)

Product codes / lots: Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Distribution: US Nationwide distribution.
Firm notified the public via: Telephone
FDA event ID: 99698
Recall initiated: July 31, 2026
FDA classified: September 11, 2026
FDA report date: September 23, 2026

Other medical device recalls from around the same time

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.FDA · September 23, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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