Z-1881-2026Class II

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M...

Name: Z-1881-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M...
Creator: Medline Industries, LP
Published: 2026-02-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified / root cause: design

FDA source

Medline Industries, LP began a recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602... on 2026-02-27. FDA classified it as Class II and gives the reason as "Unapproved design changes to the products outside of the 510(k) clearance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1881-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-04-17
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
Product code: FDE Laparoscopy Kit
Reason for recall: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause tag: design
FDA root cause: Component change control
Action: On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Quantity in commerce: 270,311 total
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Product codes and lots: DYNJ905153M UDI-DI 10195327556761 (EA) 40195327556762 (CS) LOT 24CMG485 DYNJ905153N UDI-DI 10198459017797 (EA) 40198459017798 (CS) LOT 25DMC254 DYNJ81602 UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT 24ABP080 DYNJ905157K UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349 24EMC297 DYNJ905157L UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS 24FMD083 24HMD400 24IME332 24JMA234 24KMG588 25AMA393 25AMJ541 25BMI202 25CMD909 25CMH371 DYNJ46675G UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT 24ABS814 DYNJ81607 UDI-DI 10195327123918 (EA) 40195327123919 (CS) LOT 24ABP097 DYNJ905160O UDI-DI 10198459017742 (EA) 40198459017743 (CS) LOTS 24HMG093 24IME714 24JMI924 24LMB556 25AME613 25BMJ076 DYNJ81599 UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT 24BBB847 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ905153M lots 24BMH968 24EMG682; DYNJ905153N lots 24HMG087 24IMA442 24IMG245; DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1881-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1877-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1878-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1879-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1880-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1881-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1882-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1883-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1884-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1885-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1886-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1887-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1888-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1889-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1890-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1891-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1892-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17

Product code FDE

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)