Class II U.S. Food and Drug Administration

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance

Recall published 6 months ago

Unapproved design changes to the products outside of the 510(k) clearance.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Unapproved design changes to the products outside of the 510(k) clearance.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1877-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
270,311 total
Distribution
Nationwide
Made in
United States
Lot / code info
DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333 (EA) 40195327397334 (CS) LOTS 23DBP804 23FBH420 23GBF219 23HBJ487 23IBO358 23KBA337 23LBC194 24ABI270 24CMD265 24CMG190 24EMJ851 24GMK004 24HMF977 24JMC975 24KMH243 24LMG715 DYNJ37724K UDI-DI 10195327531256 (EA) 40195327531257 (CS) LOTS 23JBS842 23LMF451 24BMH462 24EMI397 24EMJ503 24GMK100 24HMH553 24JMA589 24KMJ234 DYNJ38395G UDI-DI 10195327286767 (EA) 40195327286768 (CS) LOTS 22LMF926 23BMA411 23DMD076 23DMG120 DYNJ44293F UDI-DI 10195327265182 (EA) 40195327265183 (CS) LOTS 23CBH106 DYNJ44293G UDI-DI 10195327427276 (EA) 40195327427277 (CS) LOTS 23HBI186 23HBX788 23IBP108 23JBQ388 23JBT471 23KBX452 23LBU382 24ABH531 24ABU590 24CBQ251 24FBS495 24HBB684 DYNJ44293J UDI-DI 10198459252471 (EA) 40198459252472 (CS) LOTS 25ABS436 25CBC411 25DBS739 25EBN111 25GBK945 DYNJ47665F UDI-DI 10195327355210 (EA) 40195327355211 (CS) LOTS 23GMI750 23IMG679 DYNJ47665G UDI-DI 10195327535810 (EA) 40195327535811 (CS) LOTS 23KMC220 23LMD957 24AMH318 24CMC513 24CMF048 24EMF765 24FMB398 24GMD088 24HMG619 24KMC285 DYNJ51126C UDI-DI 10195327299996 (EA) 40195327299997 (CS) LOTS 24EBL991 24GBL127 24HBB815 24IBI837 24KBT622 DYNJ51239C UDI-DI 10195327663728 (EA) 40195327663729 (CS) LOTS 24FBM878 DYNJ51697C UDI-DI 10195327517267 (EA) 40195327517268 (CS) LOTS 24HBJ453 24JBQ619 24KBL433 DYNJ55359C UDI-DI 10198459167447 (EA) 40198459167448 (CS) LOTS 24JBW626 24LBJ492 25ABM557 DYNJ55359D UDI-DI 10198459253584 (EA) 40198459253585 (CS) LOTS 25CBJ836 25EBB180 25FBC620 DYNJ56666D UDI-DI 10195327366780 (EA) 40195327366781 (CS) LOTS 23FMB079 23HMC084 23JMH176 DYNJ57723C UDI-DI 10195327533007 (EA) 40195327533008 (CS) LOT 24GMA688 DYNJ62595C UDI-DI 10195327386511 (EA) 40195327386512 (CS) LOTS 23FBD527 23FBK131 DYNJ62595D UDI-DI 10195327482626 (EA) 40195327482627 (CS) LOTS 23IBD384 23JBT585 23KBV027 23LBS746 24ABX161 24BBA663 24DBO214 24EBN761 24GBJ844 24IBT077 24JBX775 24KBR861 DYNJ62858C UDI-DI 10195327265212 (EA) 40195327265213 (CS) LOTS 23GMB070 24BMD149 24HMA369 24HMJ618 24JME908 DYNJ63434D UDI-DI 10195327611200 (EA) 40195327611201 (CS) LOTS 24BBU728 24CBK568 24FBE982 24GBP703 24HBS440 24JBD723 24JBN341 24LBQ810 DYNJ65162B UDI-DI 10195327443948 (EA) 40195327443949 (CS) LOTS 23KBA866 23LBL832 DYNJ66366D UDI-DI 10195327493387 (EA) 40195327493388 (CS) LOTS 23LMC414 24BMD428 24EMG916 24EMJ523 24GMC227 24GMG298 24GMI398 DYNJ66366F UDI-DI 10198459033117 (EA) 40198459033118 (CS) LOTS 24HMI310 24IMB847 24IMD381 DYNJ66631A UDI-DI 10195327225193 (EA) 40195327225194 (CS) LOTS 23ABB849 23ABP692 23BBP518 23HB…
UPC codes
10195327506575, 40195327506576, 10198459246234, 40198459246235, 10195327327385, 40195327327386, 10195327450366, 40195327450367, 10195327459642, 40195327459643, 10195327429713, 40195327429714, 10195327140687, 40195327140688, 10195327226022, 40195327226023, 10195327363673, 40195327363674, 10195327201418, 40195327201419

Products covered by this recall

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246

Check your product

The notice names 27 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10195327506575
  • 40195327506576
  • 10198459246234
  • 40198459246235
  • 10195327327385
  • 40195327327386
  • 10195327450366
  • 40195327450367
  • 10195327459642
  • 40195327459643
  • 10195327429713
  • 40195327429714
  • 10195327140687
  • 40195327140688
  • 10195327226022
  • 40195327226023
  • 10195327363673
  • 40195327363674
  • 10195327201418
  • 40195327201419

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24ABR861 DYNJ0516014AI UDI-DI 10198459246234
  • 23IMD713 DYNJ37211J UDI-DI 10195327363673
  • 23CBH106 DYNJ44293G UDI-DI 10195327427276
  • 24FBM878 DYNJ51697C UDI-DI 10195327517267
  • 24GMA688 DYNJ62595C UDI-DI 10195327386511
  • 23ABB849 23ABP692 23BBP518 23HB

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mL

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Medline Industries, LP — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  3. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  4. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Unapproved design changes to the products outside of the 510(k) clearance. Unapproved design changes to the products outside of the 510(k) clearance.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327506575, 40195327506576, 10198459246234; lot code 24ABR861 DYNJ0516014AI UDI-DI 10198459246234, 23IMD713 DYNJ37211J UDI-DI 10195327363673, 23CBH106 DYNJ44293G UDI-DI 10195327427276. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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