Z-2583-2026Class II

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J...

Name: Z-2583-2026 Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J...
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 Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF... on 2026-02-27. FDA classified it as Class II and gives the reason as "Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601". 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-2583-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-06-25
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Product code: FDE Laparoscopy Kit
Reason for recall: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Root cause tag: design
FDA root cause: No Marketing Application
Action: This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
Quantity in commerce: 113,843 kits
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Product codes and lots: DYNJ905153J UDI-DI 10193489395464 Lots 21HBD986 21HBO570 21JBK103 21LBC610 22BBV026 22CME902 22GMG562 DYNJ905153K UDI-DI 10195327187866 Lots 22IMF393 22JMG893 23AMG164 23BMB570 DYNJ905153L UDI-DI 10195327405519 Lots 23FME792 23GMD683 23JMF608 23JMG151 DYNJ49593A UDI-DI 10889942275700 Lot 21FBM893 DYNJ46550K UDI-DI 10195327466992 Lot 24CMB215 DYNJ905157G UDI-DI 10193489397420 Lots 21BBG946 21DBD729 21EBO606 21HBN881 21IBE897 21KBA400 21KBO309 21LBC591 21LBG289 22CBV171 22DMI216 22EMH096 22FMC402 22GMG222 22OBE713 DYNJ905157I UDI-DI 10195327219925 Lots 22LMA455 22LMG933 DYNJ905157J UDI-DI 10195327406004 Lots 23GMB987 23IMA700 DYNJ56930B UDI-DI 10193489631289 Lot 24BBD644 DYNJ905160J UDI-DI 10193489908954 Lots 21GBT443 21HBN882 21JBA979 21KBA397 21KBA398 21LBH668 22CBV042 22DMI217 22EMB282 22EME050 22GMG599 22NBB158 DYNJ905160K UDI-DI 10195327187965 Lots 22IMF392 22JME891 22LME862 23AMB124 23AMB378 23AMC123 23BMB201 23BMF724 DYNJ905160M UDI-DI 10195327556723 Lots 23KMD689 23LMC509 24BMA402 DYNJ0843063K UDI-DI 10195327286460 Lots 23ADB394 23BDA963 23CDC020 23EDA191 23FDB421 23HDC666 23JDA179 23LDA280 DYNJ80196 UDI-DI 10195327014469 Lot 25CBK877 DYNJ908706 UDI-DI 10195327154585 Lots 22HMG258 23AMC139 23AME093 23AMH476 23BMF735 DYNJ908706B UDI-DI 10195327556907 Lots 23LMC084 24AMC273 24BMJ061 24CMC665

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2583-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2581-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2582-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2583-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2584-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2585-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2586-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2587-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2588-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2589-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2590-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2591-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2592-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2593-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2594-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2595-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2596-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25

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)