FDA Class I Recall: Pediatric care bed; Product Designation: KayserBett IDA; by KAYSERBETTEN GMBH & CO. KG — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is KAYSERBETTEN GMBH & CO. KG and the affected product is described in FDA's record as: Pediatric care bed; Product Designation: KayserBett IDA;. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2212-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Pediatric care bed; Product Designation: KayserBett IDA; -- and the recall number Z-2212-2026. If it matches, stop using or distributing it and contact KAYSERBETTEN GMBH & CO. KG or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

KAYSERBETTEN GMBH & CO. KG’s FDA history

Argus HQ has recorded 1 total FDA action tied to KAYSERBETTEN GMBH & CO. KG: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

KAYSERBETTEN GMBH & CO. KG recalled Pediatric care bed; Product Designation: KayserBett IDA;. FDA's record states the reason for recall as: 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 (additional items listed in FDA's full record). The recall.

How serious is this recall?

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.

What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Pediatric care bed; Product Designation: KayserBett IDA;) and recall number Z-2212-2026, then follow KAYSERBETTEN GMBH & CO. KG's recall instructions.

Related enforcement actions