Reported Jul 1, 2026 · Ongoing
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- 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 codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 10195327536145Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 2 10193489345544101934899646151019532728655210889942186679Lot 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 3 Lot 24BBE416 - Amount recalled
- 113,843 kits
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
Why it was recalled
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
This product could cause temporary or reversible health problems — stop using it.
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