Class II Recall

1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medlin

Summary

The FDA issued a Class II for 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Pro by Medline Industries, LP. Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribut.

Details

Source

Device Recall

External ID

Z-0169-2027

Action Date

2026-10-21

Status

Ongoing

Product Description

1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879; 10) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879C; 11) Product Name CARDIAC SURGERY, Medline Kit Number/SKU DYNJ911589A; 12) Product Name AV SHUNT-MARYVIEW, Medline Kit Number/SKU DYNJ911710; 13) Product Name CARDIAC ACCESSORY PACK, Medline Kit Number/SKU DYNJT7607.

Lot/Code Info: Medline product number/SKU DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 26ADA368; Medline product number/SKU DYNJT7607, UDI/DI 10198459639470 (each) 40198459639471 (case), Lot Number 26ABP608; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25KLA755; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25KDA055; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25JLA081; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25JBQ932; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25IDA242; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25HBV035; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ELA868; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25EDA603; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA807; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA545; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ALA107; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA717; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA627; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24KLA675; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24KBD462; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24JLA497; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24IBQ955; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24HLA074; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24HDA135; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24GLA306; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24GBA028; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24FLA524; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24FBI615; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24EDA934; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24BLA262; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23LLA290; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23LDA007; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB898; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB325; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ILA783; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23IDB477; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA825; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA102; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23EMA351; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23EDC422; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23DLA106; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23CME779; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23CLA041; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23CDB348; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDB876; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDA883; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ALA790; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22KLB130; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22JLA337; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22ILA503; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22HLB081; Medline product number/SKU DYNJ908879, UDI/DI 10195327203429 (each) 40195327203420 (case), Lot Number 22HBX489; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22HBR302; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22GLA012; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22FBR986; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22DLA370; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22CLA935; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22CBY756; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21VBC303; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBE903; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBD590; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBO692; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBK081; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABW871; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABB682.

Quantity Affected: 1834 kits

Reason for Recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-02

Company

Medline Industries, LP

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 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.

Medline Industries, LP has 607 FDA actions in our database, including 576 recalls and 31 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 607 FDA actions in our database, including 576 recalls and 31 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0169-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29