Hazard

Inflation Device recalls

9 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2026-01-28

Of the 9 inflation device recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inflation device recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–9 of 9

HighFDA (Devices)·Z-1126-2026·2026-01-28
Custom inflation kits recalled over inflation handles that may detach
Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.
Product
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-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2026·2026-01-28
Custom procedure kits recalled over inflation handles that may detach
Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2026·2026-01-28
Angioplasty packs recalled over inflation handles that may detach
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2026·2026-01-28
basixCOMPAK inflation devices recalled over handles that may detach
Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.
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 IN4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2026·2026-01-28
Waste management vascular trays recalled over inflation handles that may detach
Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0413-2026·2026-01-28
Custom manifold kits recalled over inflation handles that may detach
Merit Medical Systems is recalling 2,192 Custom Manifold Kits, REF K09-13203A, because the inflation device handle may detach from the syringe during a procedure.
Product
Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1124-2026·2026-01-28
Angiographic inflation devices recalled over handles that may detach
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.
Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2533-2025·2025-09-17
Encore 26 inflation devices recalled over foreign material particles migrating into catheters
Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.
Product
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2534-2025·2025-09-17
Encore Advantage kits recalled over particles migrating from the inflation device
Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.
Product
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Category
Medical Device
Distribution
0 states