← FDA ENFORCEMENT
Z-2697-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-07-15
Distribution
US Nationwide distribution.
Firm state
IL
Product quantity
396 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.

Product description

Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C

Code / lot info

1) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 25ABO124; 2) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBT583; 3) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBB032; 4) DYNJ88569A, UDI-DI: 10198459309649(each), 40198459309640(case), Lot Number: 25DBF217; 5) DYNJ88569B, UDI-DI: 10198459505669(each), 40198459505660(case), Lot Number: 25JBP861; 6) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 26ABE456; 7) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 25KBI025

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.