Pediatric care bed; Product Designation: KayserBett IDA;

FDA device recall Z-2212-2026 · posted 2026-06-04 · Open, Classified

Recall details

Recalling firm

KAYSERBETTEN GMBH & CO. KG

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).

Action taken

On May 4, 2026 Urgent Field Safety Notice letters were sent to customers. Actions to be taken: Please inform all users and operators of a KayserBett IDA that by implementing the following safety measures, the above-mentioned risk to patients or third parties can be eliminated during further use of the product. If the patient is unattended, " the sleeping platform must be lowered to its lowest position. " the adjustment functions on the hand control must be locked using a key. " the doors must be closed. KayserBetten is implementing a corrective action to replace the hand control on all affected KayserBett IDA beds in the U.S. field with a modified hand control featuring an automatic locking function (Auto-Lock). With the new hand control, the adjustment functions lock automatically after each use, eliminating the dependence on the caregiver manually locking the hand control with a key. The hand control replacement will be performed by an authorized service technician at no cost to the customer. Your U.S. distributor, Mobility Unlimited Inc. (DBA KayserBetten US), will contact you to schedule the replacement. Please ensure in your organization that all users of the above-mentioned product and other persons to be informed are aware of this Field Safety Notice. If you have supplied the products to third parties, please forward a copy of this information or inform the contact person listed below. Please keep this information at least until the hand control replacement has been completed.

Root cause

Device Design

Status

Open, Classified

Product code

FNL

Quantity affected

372 units

Distribution

Distribution US Nationwide and Canada.

Date initiated

2026-05-04

Date posted

2026-06-04

Location

Bad Fallingbostel, Germany