FDAFDA recall Z-2418-2026 · Jun 24, 2026
Medline Industries, LP: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C recall
Recall found
Product
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Reason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- DYNJ61460C UDI-DI 10198459422133 lot 25KBA098 CDS840150Y UDI-DI 10198459303029 lots 25JBW220 26BBD028 DYNJ56297C UDI-DI 10198459513954 lot 25LMJ874 DYNJT3454 UDI-DI 10198459325663 lot 25KBG761 DYNJ33822L UDI-DI 10198459385582 lot 26AMA072 DYNJ900962O UDI-DI 10198459452581 lot 26CBC302 DYNJ54238L UDI-DI 10198459443114 lot 25LMH549 DYNJT6766 UDI-DI 10198459580888 lot 25KBM870 DYNJ909794C UDI-DI 10198459528002 lot 25LBF702 CVI5323A UDI-DI 10198459582035 lot 25KBM758 CDS983040M UDI-DI 10198459579813 lots 25KBO682 26BBB926
- Quantity
- 49,654 kits total
- Distribution
- US Nationwide distribution. OUS distribution pending.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-27
Source: openFDA enforcement record Z-2418-2026 · search recall number Z-2418-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.