Recall Z-2212-2026— KAYSERBETTEN GMBH & CO. KG
Class I · Ongoing
Class I FDA medical device recall by KAYSERBETTEN GMBH & CO. KG, initiated 2026-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Pediatric care bed; Product Designation: KayserBett IDA;. Reason: 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)..
- Recalling firm
- KAYSERBETTEN GMBH & CO. KG
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-05-04
- Firm location
- Bad Fallingbostel, Germany
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.