SEDECAL SA: Medical Device Recall in 2025 - (Recall #: Z-0242-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: October 29, 2025

Recall Number: Z-0242-2026

Event ID: 97075

Reason for Recall:

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Status: Ongoing

Product Quantity: 56 units

Code Information:

UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.

Distribution Pattern:

US: CA, IL, and NJ

Voluntary or Mandated:

Voluntary: Firm initiated