KAYSERBETTEN GMBH & CO. KG: Pediatric care bed; Product Designation: KayserBett IDA;

Recall number

Z-2212-2026

Recalling firm

KAYSERBETTEN GMBH & CO. KG

Product

Pediatric care bed; Product Designation: KayserBett IDA;

Status

Open, Classified

Initiated

2026-05-04

Posted

2026-06-04

Terminated

not on file

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).

Root cause

Device Design

Action

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.

Quantity

372 units

Distribution

Distribution US Nationwide and Canada.

Lot, serial or model codes

Product Designation: KayserBett IDA; UDI-DI: 426038961IDAGU; Serial Number: 386, 387, 388, 389, 390, 391, 392, 635, 636, 637, 638, 639, 641, 642, 643, 644, 645, 646, 647, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1090, 1110, 1111, 1446, 1447, 1448, 1449, 1648, 1649, 1950, 1975, 1976, 1982, 1983, 1998, 2001, 2003, 2004, 2337, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2396, 2763, 2764, 2765, 2766, 2767, 2770, 2771, 2772, 2773, 2774, 3087, 3088, 3089, 3090, 3091, 3092, 3167, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3309, 3310, 3311, 3312, 3313, 3314, 3740, 3741, 3760, 4223, 4232, 4233, 4234, 4235, 4236, 4237, 4239, 4240, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4579, 4580, 4581, 4582, 4583, 4584, 4986, 5238, 5254, 5255, 5256, 5257, 5258, 5259, 5637, 5919, 5920, 5921, 5922, 5923, 5924, 5925, 5926, 5937, 5938, 5939, 5940, 5948, 6332, 6338, 6339, 6340, 6341, 6342, 6343, 6344, 6345, 6346, 6347, 6351, 6355, 6795, 6796, 7176, 7177, 7178, 7179, 7180, 7181, 7182, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7617, 7618, 7619, 7620, 7621, 7622, 7623, 8242, 8243, 8244, 8245, 8588, 8589, 8590, 8591, 8592, 8593, 8594, 8595, 8596, 8597, 8598, 8599, 8600, 8601, 8602, 8603, 8608, 8609, 8691, 8704, 8912, 8921, 8922, 8923, 8924, 8925, 8926, 8927, 8928, 8929, 8930, 9725, 9726, 9727, 10350, 10351, 10352, 10819, 10820, 10821, 10822, 10823, 10824, 10825, 11186, 11367, 11368, 11369, 11370, 11371, 11372, 11797, 11798, 11799, 11800, 11801, 11802, 11803, 11804, 11805, 11806, 11807, 11808, 12247, 12248, 12249, 12250, 12251, 12252, 12253, 12254, 12255, 12256, 12257, 12397, 12398, 12399, 12782, 12783, 12963, 12964, 12965, 12966, 12967, 12968, 12969, 12970, 12971, 12972, 13486, 13487, 13488, 13489, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13497, 13912, 13913, 13914, 13915, 13916, 13917, 13918, 14942, 14944, 14952, 14953, 15912, 15913, 15914, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 17577, 17578, 17579, 17580, 17581, 17582, 17583, 17584, 17585, 17586, 17587, 18494, 19112, 19113, 19114, 20151, 20152, 20153, 20154, 20155, 20156, 20157, 20158, 20963, 20964, 20965, 20966, 20967, 20968, 20969, 20970, 20972, 21192, 21193, 21194;

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

3006795806

Firm city

Bad Fallingbostel

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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