Recall Register

Food, drugs, devices › Stryker Medical Division of Stryker Corporation

Device recall: Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

FDA enforcement event 91160 · Class II · initiated 11 Nov 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordPortage, MI

Stryker Medical Division of Stryker Corporation (Portage, MI) initiated this device recall on 11 Nov 2022; FDA lists 1 product record under event 91160, classified Class II.

FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Stryker Medical Division of Stryker Corporation has 37 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Stryker Medical Division of Stryker Corporation, Portage, MI.

Reason for recall

"Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected."

Distribution

"Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom."

Product records

Recall numberProductQuantityClassStatusReport date
Z-0479-2023Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)465 (403 US; 62 OUS)Class IIOngoing21 Dec 2022

Context

88%of 2022 device events are Class II839 events that year
1product record in this eventfirm median: 1
37events on this register for the firm

Other enforcement events for Stryker Medical Division of Stryker Corporation

InitiatedProduct (first record)TypeClassRecords
18 Feb 2026Cub Pediatric Crib, Model FL19HDeviceClass II1
31 Oct 2025Stryker MV3 bariatric bed, Part Number 5900000001DeviceClass II2
30 Aug 2023ProCuity bed series, model number 3009, item number: 300900000000,DeviceClass II13
24 May 2023Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractablDeviceClass II1
1 Feb 2023Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. ModDeviceClass II1
12 May 2021Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part NumbDeviceClass II19
12 Aug 2020Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microDeviceClass II1
7 Apr 2020Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that isDeviceClass II1
20 Nov 2018Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000DeviceClass II1
10 Oct 2018Naera Hospital Bassinet, Model No. 4402DeviceClass II1

All 37 events for Stryker Medical Division of Stryker Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.