Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F
Summary
The FDA issued a Class II for Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. by Medline Industries, LP. Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601..
Details
Source
Device Recall
External ID
Z-2587-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F
Lot/Code Info: DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416
Quantity Affected: 113,843 kits
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-27
Company
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 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
Medline Industries, LP has 465 FDA actions in our database, including 435 recalls and 30 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 465 FDA actions in our database, including 435 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2587-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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