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RecallWatchMedical Device Safety
Class IIOngoingZ-1562-2026

Medline Industries, LP recalls Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART

Medline Industries, LPNorthfield, IL, United StatesReported Mar 18, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

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 containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

Lot / code information

UDI
10193489496635(each), 40193489496636(case)
Lot #
22KMG297; 2) DYNJ902487A
UDI
10193489496635(each), 40193489496636(case)
Lot #
22FMA481; 3) DYNJ902487A
UDI
10193489496635(each), 40193489496636(case)
Lot #
21IMG797; 4) DYNJ902487A
UDI
10193489496635(each), 40193489496636(case)
Lot #
21HMG569; 5) DYNJ902487A
UDI
10193489496635(each), 40193489496636(case)
Lot #
21HMB801; 6) DYNJ908126
Show 74 more code fields
UDI
10193489980110(each), 40193489980111(case)
Lot #
26ABL637; 7) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25JBN467M; 8) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25JBN467; 9) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25JBG183; 10) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25HBF488; 11) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25GBK350; 12) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25FBO822; 13) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBT976; 14) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBP602; 15) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBP589; 16) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBP588; 17) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBP587; 18) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25EBP586; 19) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25DBB810; 20) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
25ABA001; 21) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24HBM020; 22) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24GBC436; 23) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24FBS256; 24) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24BBP532; 25) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24BBA256; 26) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
24ABN040; 27) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23JBP214; 28) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23JBJ077; 29) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23IBQ646; 30) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23HBU475; 31) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23GBE710; 32) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23GBE709; 33) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23FBF593; 34) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23DBJ852; 35) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
23DBC954; 36) DYNJ908126
UDI
10193489980110(each), 40193489980111(case)
Lot #
22KBO714; 37) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
25IBK435; 38) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
25HBT069; 39) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
25HBO806; 40) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
25HBH137; 41) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
25GBA989; 42) DYNJ910851
UDI
10198459155895(each), 40198459155896(case)
Lot #
24LBJ019

What the firm is doing

An URGENT MEDICAL DEVICE PRODUCT ADVISORY notification dated 1/30/25 was sent to customers. REQUIRED ACTION: 1.Actions to be taken are indicated on the attached recall notification from Cardinal Health. 2.Please use the link and the information below to complete your response form stating that you have received, read, understand and performed any actions as specified in the notification from CardinalHealth. Website link: https://recalls.medline.com Recall Reference #: R-26-006-FGX2 Recall Code: 3.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 communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.

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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