Class IIOngoingZ-1842-2026

Medline Industries, LP recalls Medline Kits: 1) NEWBORN ADMISSION

Medline Industries, LPNorthfield, IL, United StatesReported Apr 29, 2026 · 2 months ago

Legal News Analyst · Apr 29, 2026

Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

Lot / code information

UDI: 10193489502428(each), 40193489502429(case)
Lot #: 22GBJ869; 2) DYNDA3188
UDI: 10198459303579(each), 40198459303570(case)
Lot #: 25DBF256; 3) DYNJG001027B
UDI: 10198459065453(each), 40198459065454(case)
Lot #: 25ELA998; 4) DYNJG001027B
UDI: 10198459065453(each), 40198459065454(case)
Lot #: 25ELA723; 5) DYNJTUMSYR
UDI: 10884389882054(each), 40884389882055(case)
Lot #: 21BBH579; 6) DYNJTUMSYR

What the firm is doing

An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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