MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Summary
The FDA issued a Class II for MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; by Bayer Medical Care, Inc.. Reason: Some devices may not have been properly sterilized due to a manufacturing sterilization issue..
Details
Source
Device Recall
External ID
Z-3147-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Lot/Code Info: Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Quantity Affected: 27800 kits (556 boxes)
Reason for Recall
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Indianola, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Bayer Medical Care, Inc. has 7 FDA actions in our database, including 4 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bayer Medical Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Medical Care, Inc. have FDA actions?
Bayer Medical Care, Inc. has 7 FDA actions in our database, including 4 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3147-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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