Class II U.S. Food and Drug Administration

Medline Kits: 1) CATH LAB CDS recall: The 510(k) regulatory clearances for certain Control Syringes

Recall published 6 months ago

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1835-2026
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
160883 units
Distribution
Nationwide
Made in
United States
Lot / code info
1) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25ALA420; 2) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25CLA774; 3) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 24LLA038; 4) DYNDH2104, UDI-DI: 10198459273964(each), 40198459273965(case), Lot Number: 25DBR609; 5) DYNJT2164M, UDI-DI: 10198459003165(each), 40198459003166(case), Lot Number: 24JBT885; 6) DYNJT3078, UDI-DI: 10198459305146(each), 40198459305147(case), Lot Number: 25DBN722; 7) DYNJT4190, UDI-DI: 10198459428234(each), 40198459428235(case), Lot Number: 25HBA387; 8) DYNJT5717, UDI-DI: 10198459496684(each), 40198459496685(case), Lot Number: 26ALA778; 9) DYNJ0381139R, UDI-DI: 10198459276019(each), 40198459276010(case), Lot Number: 25JLA029; 10) DYNJ04529L, UDI-DI: 10198459391460(each), 40198459391461(case), Lot Number: 25JLA312; 11) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 24HBM316; 12) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 23HBX895; 13) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23DBP876; 14) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23FBG933; 15) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24GBE563; 16) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24HBT787; 17) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24KBC564; 18) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24LBL445; 19) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25DBF355; 20) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25EBG106; 21) DYNJ24706D, UDI-DI: 10889942297122(each), 40889942297123(case), Lot Number: 25BBB510; 22) DYNJ24802Q, UDI-DI: 10198459091476(each), 40198459091477(case), Lot Number: 25DBJ212; 23) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25EMH059; 24) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25FMA010; 25) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25GME803; 26) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 24JME497; 27) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25AME060; 28) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMA483; 29) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMI507; 30) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMB230; 31) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMF455; 32) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMB900; 33) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMI646; 34) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBA288; 35) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBB352; 36) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23LBC983; 37) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24ABR897; 38) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24EBQ350; 39) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24FBM413; 40) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24GBA097; 41) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24HBU538; 42) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24IBM289; 43) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24JBJ568; 44) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24LBL092; 45) DYNJ31944D, UDI-DI: 10193489440171(each), 4019…
UPC codes
10889942778546, 40889942778547, 10198459273964, 40198459273965, 10198459003165, 40198459003166, 10198459305146, 40198459305147, 10198459428234, 40198459428235, 10198459496684, 40198459496685, 10198459276019, 40198459276010, 10198459391460, 40198459391461, 10889942628896, 40889942628897, 10195327295639, 40195327295630

Products covered by this recall

Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82

Check your product

The notice names 60 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.

  • 10889942778546
  • 40889942778547
  • 10198459273964
  • 40198459273965
  • 10198459003165
  • 40198459003166
  • 10198459305146
  • 40198459305147
  • 10198459428234
  • 40198459428235
  • 10198459496684
  • 40198459496685
  • 10198459276019
  • 40198459276010
  • 10198459391460
  • 40198459391461
  • 10889942628896
  • 40889942628897
  • 10195327295639
  • 40195327295630

Lot or batch code

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

  • 25ALA420
  • 25CLA774
  • 24LLA038
  • 25DBR609
  • 24JBT885
  • 25DBN722
  • 25HBA387
  • 26ALA778
  • 25JLA029
  • 25JLA312
  • 24HBM316
  • 23HBX895
  • 23DBP876
  • 23FBG933
  • 24GBE563
  • 24HBT787
  • 24KBC564
  • 24LBL445
  • 25DBF355
  • 25EBG106

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS840228F
  • DYNDH2104
  • DYNJT2164M
  • DYNJT3078
  • DYNJT4190
  • DYNJT5717
  • DYNJ0381139R
  • DYNJ04529L
  • DYNJ07955L
  • DYNJ24619J
  • DYNJ24706D
  • DYNJ24802Q
  • DYNJ30268K
  • DYNJ30927R
  • DYNJ31944D
  • DYNJ33061D
  • DYNJ34638K
  • DYNJ38120C
  • DYNJ40904G
  • DYNJ41057D

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 Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping 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?

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889942778546, 40889942778547, 10198459273964; lot code 25ALA420, 25CLA774, 24LLA038; model number CDS840228F, DYNDH2104, DYNJT2164M. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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