Class II U.S. Food and Drug Administration

Merit Medical Inflation Device.basixCompak.30 atm/bar.20 mL Reference recall: Inflation device handle may detach from the syringe during procedure

Recall published 9 months ago

Inflation device handle may detach from the syringe during procedure.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Inflation device handle may detach from the syringe during procedure.

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-1123-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Merit Medical Systems, Inc.
Product type
Medical devices
Units affected
4,163,123 units
Distribution
Nationwide
Made in
United States
Lot / code info
Reference Number/UDI Number/Lot Number(s) ENDO-AN2030/B 00884450645161 I2559664 00884450645161 I2617758 00884450645161 I2622046 00884450645161 I2657805 00884450645161 I2937082 00884450645161 I3056430 00884450645161 I3085664 00884450645161 I3118225 00884450645161 I3251180 00884450645161 I3282751 IN4130/CNK 00884450636695 I2559550 00884450636695 I2559551 00884450636695 I2563338 00884450636695 I2563339 00884450636695 I2563340 00884450636695 I2564655 00884450636695 I2564665 00884450636695 I2567481 00884450636695 I2567482 00884450636695 I2567483 00884450636695 I2578099 00884450636695 I2578100 00884450636695 I2584021 00884450636695 I2584024 00884450636695 I2584025 00884450636695 I2584026 00884450636695 I2607299 00884450636695 I2607301 00884450636695 I2607302 00884450636695 I2617759 00884450636695 I2617760 00884450636695 I2628998 00884450636695 I2629000 00884450636695 I2629001 00884450636695 I2629002 00884450636695 I2630702 00884450636695 I2648658 00884450636695 I2648659 00884450636695 I2648660 00884450636695 I2648661 00884450636695 I2657828 00884450636695 I2657833 00884450636695 I2657884 00884450636695 I2657889 00884450636695 I2663025 00884450636695 I2663026 00884450636695 I2663027 00884450636695 I2669899 00884450636695 I2669900 00884450636695 I2674531 00884450636695 I2674532 00884450636695 I2682701 00884450636695 I2682702 00884450636695 I2684463 00884450636695 I2684522 00884450636695 I2684523 00884450636695 I2699591 00884450636695 I2699592 00884450636695 I2703002 00884450636695 I2703003 00884450636695 I2703004 00884450636695 I2703006 00884450636695 I2703081 00884450636695 I2703082 00884450636695 I2703083 00884450636695 I2707735 00884450636695 I2707736 00884450636695 I2715012 00884450636695 I2715013 00884450636695 I2719928 00884450636695 I2719929 00884450636695 I2719930 00884450636695 I2719931 00884450636695 I2719933 00884450636695 I2752077 00884450636695 I2752078 00884450636695 I2755218 00884450636695 I2755219 00884450636695 I2755496 00884450636695 I2760565 00884450636695 I2773971 00884450636695 I2773972 00884450636695 I2784600 00884450636695 I2784603 00884450636695 I2844301 00884450636695 I2853612 00884450636695 I2853613 00884450636695 I2853615 00884450636695 I2858649 00884450636695 I2858650 00884450636695 I2858651 00884450636695 I2869290 00884450636695 I2886413 00884450636695 I2886423 00884450636695 I2886429 00884450636695 I2886432 00884450636695 I2887831 00884450636695 I2887832 00884450636695 I2887836 00884450636695 I2888430 00884450636695 I2892032 00884450636695 I2892033 00884450636695 I2894577 00884450636695 I2902444 00884450636695 I2902445 00884450636695 I2902446 00884450636695 I2902447 00884450636695 I2903533 00884450636695 I2903535 00884450636695 I2917165 00884450636695 I2917167 00884450636695 I2921904 00884450636695 I2921905 00884450636695 I2927911 00884450636695 I2933517 00884450636695 I2937693 00884450636695 I2937694 00884450636695 I2971987 00884450636695 I2973163 00884450636695 I2973184 00884450636695 I2976519 00884450636695 I2976520 00884450636695 I2976521 00884450636695 I2983704 00884450636695 I2986048 00884450636695 I2986049 00884450636695 I2989136 00884450636695 I2989137 00884450636695 I3001128 00884450636695 I3001129 00884450636695 I3001130 00884450636695 I3001131 00884450636695 I3013083 00884450636695 I3013085 00884450636695 I3014308 00884450636695 I3014309 00884450636695 I3014311 00884450636695 I3014312 00884450636695 I3044881 00884450636695 I3048387 00884450636695 I3056432 00884450636695 I3056433 00884450636695 I3067548 00884450636695 I3067549 00884450636695 I3072605 00884450636695 I3074753 00884450636695 I3074754 00884450636695 I3074755 00884450636695 I3074756 00884450636695 I3079091 00884450636695 I3079092 00884450636695 I3079093 00884450636695 I3079094 00884450636695 I3079095 00884450636695 I3079096 00884450636695 I3085666 00884450636695 I3085667 00884450636695 I3085668 00884450636695 I3097690 00884450636695 I3097691 00884450636695 I3098952 00884450636695 I3098953 00884450636695 I3098955 00884450636695 I3118…
UPC codes
00884450645161, 00884450636695

Products covered by this recall

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A

Check your product

The notice names 2 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.

  • 00884450645161
  • 00884450636695

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

Merit Medical Systems, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Merit Medical Systems, Inc. — 1600 W Merit Pkwy, South Jordan, UT, 84095-2416

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 Merit Medical Systems, Inc. medical devices recalled?

Inflation device handle may detach from the syringe during procedure. Inflation device handle may detach from the syringe during procedure.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884450645161, 00884450636695. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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