FDA recall Z-2212-2026

KAYSERBETTEN GMBH & CO. KG · Class I · device

Product

Pediatric care bed; Product Designation: KayserBett IDA;

Reason for recall

If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).

Distribution

Distribution US Nationwide and Canada.

Key facts

Status
Ongoing
Initiation date
2026-05-04
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bad Fallingbostel, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2026