Lower riskMedical device recall · FDA · Published October 5, 2020
MEDRAD Stellant FLEX Syringe Kits May Leak Fluid Due to Holes or Cracks
Bayer Medical Care recalls specific lots of MEDRAD Stellant FLEX 150 mL syringe kits that may have holes or cracks causing fluid leaks. Affected units include lot numbers 8584324-8586388 and 8585234. Consumers should check their syringes for damage and contact Bayer for details.
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Take action
Contact the company
📍Recalling firmBayer Medical Care, Inc.1 Bayer Dr · Indianola, PA 15051-9702
✎ GovInfoNow plain-language explainer
Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because some may have holes or cracks that could cause fluid leaks. This could lead to improper medication delivery or contamination if the syringe is used. Read more at govinfonow.com/recall/64125-medrad-stellant-flex-syringe-kits-may-leak-fluid-due-to.
“MEDRAD Stellant FLEX Syringe Kits May Leak Fluid Due to Holes or Cracks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64125-medrad-stellant-flex-syringe-kits-may-leak-fluid-due-to. Based on FDA recall #Z-0483-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0483-2021%22&limit=1).
The FDA announced on Oct. 5, 2020, that Bayer Medical Care is recalling MEDRAD Stellant FLEX Syringe Kits due to potential fluid leaks from holes or cracks in specific lots. The agency said the recall involves 92,420 units distributed to healthcare facilities nationwide.
Lot Numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388 (FLEXD-150-SCS)
Lot Number: 8585234 (FLEXD-150-SPK)
UPC: 00616258010656
UPC: 00616258022888
The hazard
Specific lots of the 150 mL syringe kits may have holes and/or cracks that allow fluid to leak out. The FDA said this defect poses a potential safety risk during use.
Context
GovInfoNow's records show Bayer Medical Care has issued seven other recalls since June 28, 2018. Recent brand recalls include the July 31, 2026, Stellant FLEX Syringe Kit recall for sterilization issues and the April 24, 2026, Avanta Tube Sets recall for stopcock disengagement risk. Other recent recalls of similar products include the Dec. 12, 2025, Medline medical kit recall due to cracked butyrate tubing and the Feb. 27, 2026, Medline medical kits recall for syringe disconnection risk.
How to tell if you have this one
Check for lot numbers 8584324 through 8586388 or 8585234 on the syringe kit packaging. The MEDRAD Stellant FLEX syringe kits are used for angiographic procedures and come with specific components like saline and contrast spikes.
Look for lot numbers 8584324-8586388 or 8585234 on the syringe kit packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed to healthcare facilities nationwide throughout the US.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0483-2021 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0483-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.