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ModerateClass IITerminated

FDA Devices recall · Reported April 25, 2018

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended us

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

Recall #
Z-1389-2018
Affected scope
4724
Initiated
March 12, 2018
Verify with FDA Devices →
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Stryker Medical Division of Stryker Corporation recalled Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 … - a moderate-severity action.

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 … was recalled by Stryker Medical Division of Stryker Corporation in April 25, 2018. Reason: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be br…. Check the official notice for the remedy. Verify recall #Z-1389-2018 with the FDA Devices before acting.

The recall

Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be br….

Moderate
severity level
5K units
affected scope
Class II
classification
April 25, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1389-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.

Reason for recall

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1389-2018
Date reported April 25, 2018
Date initiated March 12, 2018
Recalling firm Stryker Medical Division of Stryker Corporation
Firm location Portage, MI
Affected scope 4724
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

4724 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1389-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 4724.
Why was this product recalled? ▼
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1389-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported April 25, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026