Agency classClass IIOur severity:High FDA (Devices)·Z-2479-2025·Announced 2025-09-03

Surgical kits recalled because Foley tray inserts carry incorrect product information

Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential injury requiring medical intervention and reports no injuries.

Plain-English summary

Medline kits containing BD SureStep Foley Tray Systems are being recalled under SKUs CDS984076J (GYN Robotic), DYNJG001004A (LAVH Minor), DYNJG901001B (Craniotomy) and DYNJ908819B (Kit Craniotomy). Only units from SKU DYNJG001004A were distributed. The recall covers 4 units distributed in Florida and Illinois, with no distribution outside the United States reported.

The kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. The manufacturer states that if a mislabeled tray is used, patient risk ranges from minor injury to injury requiring medical intervention, such as infection or a local or systemic allergic reaction including anaphylaxis. The FDA classified the action as Class II.

Hospitals holding affected kit lot numbers should quarantine them and follow Medline's instructions for return or replacement.

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 — Procedure Kits
Hazard: incorrect-insert
mislabeling
infection-risk
class-ii
Affected units: 4

Distribution

Distributed in 2 states:

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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