CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
ProCuity bed series recalled by Stryker Medical Division of
Stryker Medical Division of Stryker is recalling ProCuity bed series, distributed nationwide in the US. The recall was initiated on 30 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0427-2024
- FDA event ID
- 93317
- Recalling firm
- Stryker Medical Division of Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2023
- FDA classified
- 1 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Aug 2023 | Recall initiated by company | |
| 1 Dec 2023 | Classified by FDA | +93 days |
| 13 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product as listed by the FDA
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Where it was distributed
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Questions about this recall
Why was it recalled?
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Which lots are affected?
UDI-DI (GTIN): 07613327541182. Serial numbers: 2105002838 , 2105002832 , 2202000312 , 2202000286 , 2202000278 , 2202000180 , 2106002241 , 2106001240 , 2107001002 , 2203001053 , 2203001898 , 2112001135 , 2211002054 , 2105002782 , 2210002902 , 2210002890 , 2210002876 , 2210002858 , 2210002848 , 2111001420 , 2206001182
Where was it sold?
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 93317More recalls from Stryker Medical Division of Stryker
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cub Pediatric Crib recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | Stryker MV3 bariatric bed recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | Stryker Arise 1000EX mattress recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
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