Q’Apel Medical: 072 Aspiration System — FDA announcement Apr 18, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Apr 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
072 Aspiration System
Reason
Distal Tip Design outside scope of 510k clearance
Classification
Not supplied
Recalling firm
Q’Apel Medical, Inc.
Quantity
Not supplied
Agency-reported status
Company recall announcement
Source record identifier
975e4eaaad2dcd3f

Open the official record

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability072 Aspiration Tubing; Catalog Number: APT-95; Unique Device Identifier: 00857545008103; Lot: FG241206A-04

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

The product was distributed in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan. The Hippo product configurations described above have been discontinued in all markets. The company has proactively notified all customers and distributors and will continue to monitor the situation closely. Consignees of the product should immediately return any available product inventory to the company. If consignees have distributed the product to others, contact Q’Apel so that the company can notify them of this action and retrieve any remaining product.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date
Apr 18, 2025
Company announcement date
Apr 18, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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