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

Lot, batch or date codesUDI-DI (GTIN): 07613327512656. Serial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192

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-0424-2024
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: 300900000000,

Where it was distributed

Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Nationwide Puerto Rico

Questions about this recall

Is ProCuity bed series recalled?

Yes. Stryker Medical Division of Stryker recalled ProCuity bed series on 30 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0424-2024.

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): 07613327512656. Serial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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