The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2130-2023·Announced 2023-07-19

Ambulance stretcher base leg assembly may bend causing tip and unstable motion

Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with potential for patient harm (tip, unstable motion, operational failure), but the source text does not report any actual injuries, illnesses, or hospitalizations. Per the rubric, when injury risk is theoretical without reported cases, the score is at most 3 (High).

Plain-English summary

Stryker Medical Division of Stryker Corporation manufactures the Power-PRO 2, a powered ambulance cot designed to transport patients up to 700 pounds. The recalled units include 1,980 cots shipped between February 11, 2022 and February 1, 2023, distributed worldwide including the United States, Australia, Canada, Netherlands, Switzerland, and the United Kingdom.

The base leg assembly on these cots may bend, creating operational and safety hazards. A bent base leg can make it difficult to engage or disengage fasteners, load or unload the cot from an ambulance, or raise and lower the cot. The defect may also cause the cot to tip unexpectedly or move erratically without operator input.

This recall applies to ambulance services, hospitals, and other medical facilities that use the affected Power-PRO 2 models. Facilities with serial numbers listed in the recall notice should stop using the affected cots and contact Stryker Medical for instructions on inspection, repair, or replacement. Users can identify affected units by checking the model number (6507 or variants 650700000000, 650705550001, 650705550002) and the UDI-DI codes listed in the recall.

The recalled product

Product
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Ambulance stretcher
Hazard
Affected units
1,980

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model: 650700000000 UDI-DI: 07613327504460
  • Model: 650705550001 UDI-DI: 07613327559118
  • Model: 650705550002 UDI-DI: 07613327559125
  • Cots shipped between February 11
  • 2022 and February 1

Distribution

Distributed nationwide across the United States.

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