Z-3020-2026Class II

Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK...

Name: Z-3020-2026 Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK...
Creator: Medline Industries, LP
Published: 2026-07-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE... on 2026-07-10. FDA classified it as Class II and gives the reason as "Kits contain a potentially contaminated component which were recalled by the manufacturer". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3020-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-10
Posted: 2026-08-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 263 kits
Distribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Product codes and lots: Medline Kit SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487; Medline Kit SKU CDS840393Q, UDI/DI 10198459791673 (each) 40198459791674 (case), Lot Number 26GMA017; Medline Kit SKU CDS980895W, UDI/DI 10198459123542 (each) 40198459123543 (case), Lot Number 25LMG706; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBY147; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBR361; Medline Kit SKU CDS982028W, UDI/DI 10198459385605 (each) 40198459385606 (case), Lot Number 25LMH727; Medline Kit SKU DYNJ906903F, UDI/DI 10198459504877 (each) 40198459504878 (case), Lot Number 25JME689; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25JMF804; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25IMG539; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA930; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA516; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA196; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25KLA552; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25KBD555; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBS919; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBM122; Medline Kit SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25KBF034.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3020-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3019-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3020-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3021-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3022-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3023-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3024-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3025-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3026-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3027-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3028-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3029-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)