Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTI
Pending LLM rewrite. Source: FDA_DEVICE Z-2479-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
The recalled product
- Product
- Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
Distribution
Distributed in 2 states:
- FL
- IL
Related recalls
Same category
- SevereAbiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
FDA (Devices) · 2026-07-22
- SevereBone Marrow Tray kits recalled due to sterility failure
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- SevereABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22