FDA · Medical devices ·
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall
Bayer Medical Care, Inc. recalled MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System on September 23, 2026 because of some devices may not have been properly sterilized due to a manufacturing sterilization issue. It was sold nationwide.
Why it was recalled
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
What's recalled
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Quantity: 27800 kits (556 boxes)
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Bayer Medical Care, Inc., Indianola, PA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution. - Status
- Ongoing
- Recall number
- Z-3147-2026
- Source
- U.S. Food and Drug Administration
More medical devices recalls
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.