KAYSERBETTEN GMBH & CO. KG recalls Pediatric care bed
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).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Pediatric care bed; Product Designation: KayserBett IDA;
Lot / code information
- UDI
- 426038961IDAGU
- Serial #
386, 387, 388, 389, 390, 391 — +366 moreShow all
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
What the firm is doing
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.
DistributionShow detailsHide
Distribution US Nationwide and Canada.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2212-2026
- FDA device classification · FNLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find KAYSERBETTEN GMBH & CO. KGSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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