Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management…
Medical device recall Z-3015-2020. Published in FDA’s Enforcement Report on Oct 7, 2020.
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 Oct 7, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 4 states named
- 110 units 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?
Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
110 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 2020018700101 2020018700102 2020018700103 2020018700104 2020018700105 2020018700106 2020018700107 2020018700108 2020018700109 2020018700110 2020018700111 2020018700112 2020018700113 2020018700114 2020018700115 2020018700116…
Every code shown here, 1,583 characters
Serial Numbers: 2020018700101 2020018700102 2020018700103 2020018700104 2020018700105 2020018700106 2020018700107 2020018700108 2020018700109 2020018700110 2020018700111 2020018700112 2020018700113 2020018700114 2020018700115 2020018700116 2020018700117 2020018700118 2020018700119 2020018700120 2020018700121 2020018700122 2020018700123 2020018700124 2020018700125 2020018700126 2020018700127 2020018700128 2020018700129 2020018700130 2020018700131 2020018700132 2020018700133 2020018700134 2020018700135 2020018700136 2020018700137 2020018700138 2020018700139 2020018700140 2020018700141 2020018700142 2020018700143 2020018700144 2020018700145 2020018700146 2020018700147 2020018700148 2020018700149 2020018700150 2020018700151 2020018700152 2020018700153 2020018700154 2020018700155 2020018700156 2020018700157 2020018700158 2020018700159 2020018700160 2020018700167 2020018700169 2020018700206 2020018700209 2020018700210 2020018700211 2020018700212 2020018700213 2020018700214 2020018700239 2020018700240 2020018700241 2020018700242 2020018700243 2020018700244 2020018700245 2020018700246 2020018700247 2020018700248 2020018700250 2020018700251 2020018700252 2020018700253 2020018700254 2020018700255 2020018700256 2020018700257 2020018700258 2020018700259 2020018700260 2020018700261 2020018700262 2020018700263 2020018700264 2020018700265 2020018700266 2020018700267 2020018700268 2020018700281 2020018700282 2020018700283 2020018700284 2020018700285 2020018700286 2020018700287 2020018700288 2020018700289 2020018700290 2020018700291 2020018700292 GTIN Number: 07613327503999
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.
US Nationwide distribution including in the states of CA, FL, NY, OH.
The states and territories these words name
- California
- Florida
- New York
- Ohio
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 Aug 12, 2020.
- FDA classified it on Sep 25, 2020.
- FDA’s Enforcement Report published it on Oct 7, 2020.
- FDA terminated it on Apr 2, 2021.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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.”
- 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
-
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.