Z-2785-2026Class II

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons...

Name: Z-2785-2026 Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons...
Creator: Medline Industries, LP
Published: 2026-06-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-08 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F on 2026-06-08. FDA classified it as Class II and gives the reason as "Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of...". 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-2785-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Product code: OHD Gynecological Laparoscopic Kit
Reason for recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 8, 2026, the firm began notifying customers through First-Class Mail and email. Customers were instructed to over-label affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity in commerce: 980 kits
Distribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Product codes and lots: DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2785-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2779-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2780-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2781-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2782-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2783-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2784-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2785-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2786-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2787-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23

Product code OHD

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)