SEDECAL SA recalled five units of its Mobile X-ray system on June 10, 2025. The equipment poses a high hazard due to its lack of water resistance and improper cleaning risks. Users must stop using the device immediately and follow the recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall affects the Mobile X-ray system with model number SM-40HF-B-D-C. The UDI/DI is 08436046001510, and affected serial numbers include G35462, G-32753, G35480, G33111, and G33721. The devices distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant, which may lead to electrical hazards if not cleaned properly. Users must adhere strictly to cleaning instructions in the manual to avoid potential accidents.
No incidents have been reported yet. However, the high hazard classification indicates a significant risk associated with improper cleaning of the device.
Stop using the Mobile X-ray system immediately. Follow the instructions provided in the recall notification or contact SEDECAL SA or your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0265-2026.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.