Moderate riskFDA DeviceJan 28, 2026Class II

Merit Medical basixCOMPAK inflation device recalled for detaching handle

Merit Medical Systems' basixCOMPAK inflation device handle may detach from the syringe during a medical procedure. This affects multiple reference numbers and lots of the 20 mL, 30 atm/bar model used in clinical settings.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

If you use this device in a medical facility, stop using affected units immediately
Check your inventory against the recalled reference numbers and lot numbers
Contact Merit Medical Systems or your supplier for instructions on device replacement or return
Review your procedure protocols to prevent use of recalled devices

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected: 4,163,123 units
Illnesses reported: None reported
Manufactured in: 1600 W Merit Pkwy, South Jordan, UT, United States
Classification: Class II
Recall number: Z-1123-2026

In the FDA's words

Description: 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 Inflation device handle may detach from the syringe during procedure. 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 I3118226 00884450636695 I3118227 00884450636695 I3118228 00884450636695 I3118230 00884450636695 I3129660 00884450636695 I3129661 00884450636695 I3129662 00884450636695 I3129663 00884450636695 I3129664 00884450636695 I3146015 00884450636695 I3146016 00884450636695 I3150024 00884450636695 I3150025 00884450636695 I3150028
Hazard: Inflation device handle may detach from the syringe during procedure.

7 products in this recall

Merit Medical inflation devices and kits recalled for handle detachment

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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 IN4… (this page)
Z-1123-2026 · 4,163,123 units
Allwell Inflation Device, for angiographic use REF: IS-30-A
Z-1124-2026 · 173,645 units
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Z-1125-2026 · 864 units
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01…
Z-1126-2026 · 18,897 units
Merit Medical , Custom Manifold Kit REF: K09-13203A
Z-1127-2026 · 2192 units
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Z-1128-2026
Allwell Angioplasty Pack REF: IS-30-B1/B
Z-1129-2026 · 328000 units