Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ9013
Summary
The FDA issued a Class II for Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; by Medline Industries, LP. Reason: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots.
Details
Source
Device Recall
External ID
Z-2696-2026
Action Date
2026-07-15
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
Lot/Code Info: 1) DYNJ88569D, UDI-DI: 10198459745775(each), 40198459745776(case), Lot Number: 26DBP363; 2) DYNJ901348F, UDI-DI: 10198459216213(each), 40198459216214(case), Lot Number: 25JBQ159
Quantity Affected: 75 kits
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-28
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.
Medline Industries, LP has 492 FDA actions in our database, including 462 recalls and 30 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 492 FDA actions in our database, including 462 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2696-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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