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FDA Medical Device Recalls (openFDA)

Stryker Medical Division of Stryker Corporation: Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.

Recall number
Z-2240-2011
Recalling firm
Stryker Medical Division of Stryker Corporation
Product
Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.
Status
Terminated
Initiated
2011-04-29
Posted
2011-05-23
Terminated
2011-10-07
Reason
Affected mattresses may not conform to federal flammability standards.
Root cause
Other
Action
Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689.
Quantity
213
Distribution
Worldwide Distribution - USA including California and the country of Canada.
Lot, serial or model codes
Model number 2980: 09AC000234, 09AC000235, 09AC000236, 09AC000237, 09AC000238, 09AC000239, 09AC000240, 09AC000241, 09AC000242, 09AC000243, 09AC000244, 09AC000245, 09AC000246, 09AC000247, 09AC000248, 09EA000807, 09EA000808, 09EA000809, 09EA000810, 09EA000811, 09EA000812, 09EA00081, 09EA000814, 09EA000815, 09EA000816, 09EA000817, 09EA000818, 09EA000819, 09EA000820, 09EA000821, 09EA000822, 09EA000823, 09EA000824, 09EA000825, 09EA000826, 09EA000827, 09EA000828, 09EA000829, 09EA000830, 09EA000831, 09FA000833, 09FA000834, 09FA000835, 09FA000836, 09FA000837, 09FA000838, 09FA000839, 09FA000840, 09FA000841, 09FA000842, 09FA000843, 09FA000844, 09FA000845, 09FA000846, 09FA000847, 09FA000848, 09FA000849, 09FA000850, 09FA000851, 09FA000852, 09FA000853, 09FA000854, 09FA000855, 09FA000856, 09FA000857, 09FA000858, 09FA000859, 09FA000860, 09FA000861, 09FA000862, 09FA000863, 09FA000864, 09FA000865, 09FA000866, 09FA000867, 09FA000868, 09FA000869, 09FA000870, 09FA000871, 09FA000872, 09FA000898, 09FA000899, 09FA000900, 09FA000901, 09FA000902, 09FA000903, 09GA000920, 09GA000921, 09GA000922, 09GA000923, 09GA000924, 09GA000925, 09GA000926, 09GA000927, 09GA000928, 09JA001517, 09JA001518, 09JA001519, 09JA001520, 09JA001521, 09JA001522, 09JA001523, 09JA001524, 09JA001561, 09JA001562, 09JA001563, 09JA001564, 09JA001565, 09JA001566, 09JA001567, 09JA001568, 09JA001569, 09JA001570, 09JA001571, 09JA001572, 09JA001573, 09JA001574, 09JA001575, 09JA001576, 09JA001577, 09JA001578, 09JA001579, 09JA001580, 09JA001581, 09JA001582, 09JA001583, 09JA001584, 09JA001585, 09JA001586, 09JA001587, 09JA001588, 09JA001589, 09JA001590, 09JA001591, 09JA001592, 09JA001593, 09JA001594, 09JA001595, 09JA001596, 09JA001597, 09JA001699, 09JA001700, 09JA001701, 09JA001702, 09JA001703, 09JA001704, 09KA002025, 09KA002026, 09KA002064, 09KA002065, 09KA002066, 09KA002067, 09KA002068, 09KA002069, 09KA002070, 09KA002071, 09KA002072, 09KA002073, 09KA002074, 09KA002075, 09KA002076, 09FA000896, 09FA000897, 09AC000249, 09AC000250, 09AC000251, 09AC000252, 09AC000253, 09DA000598, 09DA000599, 09EA000832, 09HA0001046, 09HA0001047, 09HA0001048, 09HA0001049, 09HA0001050, 09HA0001051, 09HA0001052, 09HA0001053, 09HA0001054, 09HA0001055, 09HA0001056, 09HA0001057, 09HA0001058, 09HA0001059, 09HA0001060, 09HA0001061, 09HA0001062, 09HA0001063, 09HA0001064, 09HA0001065, 09HA0001066, 09HA0001067, 09HA0001068, 09HA0001069, 09HA0001070, 09HA0001071, 09HA0001072, 09HA0001073, 09HA0001074, 09HA0001075, 09HA0001076, 09HA0001077, 09HA0001078, 09HA0001079, 09HA0001080, 09JA001698, 09JA001705, 09JA001706, 09JA001707, 09JA001708, 09HA001292 and 09HA001305.
510(k) numbers
not on file
PMA numbers
not on file
Product code
IKY
Firm FEI
1831750
Firm city
Portage
Firm state
MI
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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