Changeflow GovPing Healthcare Stryker Cub Pediatric Crib Model FL19H Recall
Urgent Enforcement Amended Final

Stryker Cub Pediatric Crib Model FL19H Recall

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Summary

Stryker Medical Division of Stryker Corporation is recalling Cub Pediatric Crib, Model FL19H nationwide due to cribs sold in the USA missing two access door warning labels. The recall affects all units distributed within the US market. FDA has classified this as a Class II recall, indicating potential temporary or reversible health consequences if the hazard is not addressed.

What changed

Stryker Medical Division has initiated a Class II device recall for Cub Pediatric Crib Model FL19H due to missing two access door warning labels on cribs sold in the USA. The recall affects all units distributed nationwide. FDA classifies this as a Class II recall, indicating potential for temporary or reversible health consequences if the missing labels create a hazard during use.

Healthcare facilities and distributors should immediately identify whether they possess affected Cub Pediatric Crib Model FL19H units and ensure the missing warning labels are added before continued use. Distributors must notify their customers about the recall. Manufacturers of similar pediatric medical equipment should review their labeling processes to ensure compliance with warning label requirements.

What to do next

  1. Identify whether your facility has Cub Pediatric Crib Model FL19H in inventory
  2. Notify downstream customers if you have distributed affected cribs
  3. Add the missing access door warning labels to affected units

Archived snapshot

Apr 11, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Stryker Medical Division of Stryker Corporation

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1580-2026 · 20260325 · Ongoing

Product

Cub Pediatric Crib, Model FL19H

Reason for Recall

Cribs sold in the USA are missing two access door warning labels.

Distribution

US Nationwide distribution.

Source: openFDA Enforcement API

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Last updated

Classification

Agency
FDA
Filed
March 25th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1580-2026

Who this affects

Applies to
Manufacturers Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Product labeling Pediatric equipment
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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