Device recall: ProCuity bed series, model number 3009, item number: 300900000000,
Class II FDA enforcement event 93317. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Class II, in the words of FDA
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
Stryker Medical Division of Stryker Corporation started this device recall on 30 Aug 2023. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class II. FDA event 93317 has 13 product records. The first FDA enforcement report date is 13 Dec 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Recalling firm
Stryker Medical Division of Stryker Corporation, Portage, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
13 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0424-2024 | ProCuity bed series, model number 3009, item number: 300900000000, | Class II | Ongoing | 13 Dec 2023 | |
| Z-0425-2024 | ProCuity bed series, model number 3009, item number: 3009PX-L-100. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0426-2024 | ProCuity bed series, model number 3009, item number: 3009PX-L-200 | Class II | Ongoing | 13 Dec 2023 | |
| Z-0427-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LE-400. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0428-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LE-450. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0429-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0430-2024 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0431-2024 | ProCuity bed series, model number 3009, item number: 3009PX-Z-450. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0432-2024 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0433-2024 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0434-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0435-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. | Class II | Ongoing | 13 Dec 2023 | |
| Z-0436-2024 | ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. | Class II | Ongoing | 13 Dec 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 13Median of the firm: 1
- Events of the firm on the register
- 37
Other events of the firm
Stryker Medical Division of Stryker Corporation: all 37 events
Official channels
- FDA enforcement report Z-0424-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93317. https://recallregister.com/fda/ii/93317/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.
- How many FDA recalls does Stryker Medical Division of Stryker Corporation have?
- Stryker Medical Division of Stryker Corporation is the recalling firm in 37 enforcement events on this register. This event is 1 of them.