FDA (Devices) recall action 99062

Medline Industries, LP recalled 16 products on 2026-07-01

The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2026-07-01
Critical: 0
Units: 1,252,273

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–16 of 16

SevereFDA (Devices)··2026-07-01
Medical Device Convenience Kits with 10mL Polycarbonate Syringes Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DY
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline polycarbonate syringes recalled for unapproved design changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRA
Category
Distribution
35 states
HighFDA (Devices)··2026-07-01
Medline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ680
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYN
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
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
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.
Product
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 DYNJ905
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCES
Category
Distribution
35 states
ModerateFDA (Devices)··2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIA
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline angiography and radiology convenience kits recalled for unapproved design changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and to Barbados.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY P
Category
Distribution
35 states
SevereFDA (Devices)··2026-07-01
Medline convenience kits recalled for unapproved syringe design changes
Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PA
Category
Distribution
35 states