S3 MedSurg Bed
Medical device recall Z-2353-2016. Published in FDA’s Enforcement Report on Aug 17, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 17, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 8490 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CPU board failures cause fowler (backrest) electronic controls to stop working.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
S3 MedSurg Bed, Model 3005. Stryker Medical
8490, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MDL#: E341062; 3005S3EX; 3005S3Patriot; 3005S3Signature; 3005S3PX1; 3005S3PX2; 3005S3PX3; 3005S3PX4; 3005S3EX; Serial Numbers: 141115067 through 150615027; Serial Numbers: 141115067 141115068 141115069 141115070 141115071 141115072…
Every code shown here, 1,992 characters
MDL#: E341062; 3005S3EX; 3005S3Patriot; 3005S3Signature; 3005S3PX1; 3005S3PX2; 3005S3PX3; 3005S3PX4; 3005S3EX; Serial Numbers: 141115067 through 150615027; Serial Numbers: 141115067 141115068 141115069 141115070 141115071 141115072 141115073 141115074 141115075 141115076 141115077 141115078 141115079 141115080 141115081 141115082 141115083 141115084 141115085 141115086 141115087 141115088 141115089 141115090 141115091 141115092 141115093 141115094 141115095 141115096 141115097 141115098 141115099 141115100 141115101 141115102 141115103 141115104 141115105 141115106 141115107 141115108 141115109 141115110 141115111 141115112 141115113 141115114 141115115 141115116 141115117 141115118 141115119 141115120 141115121 141115122 141115123 141115124 141115125 141115126 141115127 141115128 141115129 141115130 141115131 141115132 141115133 141115134 141115135 141115152 141115153 141115154 141115155 141115156 141115157 141115158 141115159 141115160 141115161 141115162 141115163 141115164 141115165 141115166 141115167 141115168 141115169 141115170 141115171 141115172 141115173 141115174 141115175 141115176 141115177 141115178 141115179 141115180 141115181 141115182 141115183 141115184 141115185 141115186 141115187 141115188 141115189 141115190 141115191 141115192 141115193 141115194 141115195 141115196 141115197 141115198 141115199 141115200 141115201 141115202 141115203 141115204 141115205 141115206 141115207 141115208 141115209 141115210 141115211 141115212 141115213 141115214 141115215 141115216 141115217 141115218 141115219 141115220 141115221 141115222 141115223 141115224 141115225 141115226 141115227 141115228 141115229 141115230 141115231 141115232 141115233 141115234 141115235 141115236 141115237 141115238 141115239 141115240 141115241 141115242 141115243 141115244 141115245 141115246 141115247 141115248 141115249 141115250 141115251 141115252 141115253 141115254 141115255 141115256 141115257 141115258 141115259 141115260 141115261 141115262 141115263 141115264…
FDA’s list runs to 226,874 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distribution US nationwide, Canada, and Mexico.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 2, 2016.
- FDA classified it on Aug 8, 2016.
- FDA’s Enforcement Report published it on Aug 17, 2016.
- FDA terminated it on Jun 12, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 226,874 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.