ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase…
Medical device recall Z-0292-2016. Published in FDA’s Enforcement Report on Nov 25, 2015.
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 Nov 25, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Florida the one state its words name
- 16,410,800 (10,226,600 US:, 184,200 OUS) 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?
There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
16,410,800 (10,226,600 US:, 184,200 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60…
Every code shown here, 1,997 characters
List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60 (30/1200) 40326-0154 58051 Skintact W-60 (30/1200) 40416-0326 S&W 620 58205 S&W 620 31121-0155 58205 S&W 620 31122-0156 58205 S&W 620 31125-0159 58205 S&W 620 40730-0324 58205 S&W 620 40901-0328 58205 S&W 620 50723-0326 58205 S&W 620 50827-0329 Stable Base SBW55 50007 Stable Base SBW55 31104-0159 50007 Stable Base SBW55 31107-0321 50007 Stable Base SBW55 31108-0322 50007 Stable Base SBW55 31108-0323 50007 Stable Base SBW55 31111-0324 50007 Stable Base SBW55 31118-0325 50007 Stable Base SBW55 31119-0326 50007 Stable Base SBW55 31120-0327 50007 Stable Base SBW55 31121-0328 50007 Stable Base SBW55 31121-0329 50007 Stable Base SBW55 31122-0321 50007 Stable Base SBW55 31125-0322 50007 Stable Base SBW55 31129-0323 50007 Stable Base SBW55 31202-0324 50007 Stable Base SBW55 31203-0325 50007 Stable Base SBW55 40107-0323 50007 Stable Base SBW55 40107-0324 50007 Stable Base SBW55 40108-0325 50007 Stable Base SBW55 40109-0326 50007 Stable Base SBW55 40225-0157 50007 Stable Base SBW55 40226-0158 50007 Stable Base SBW55 40227-0151 50007 Stable Base SBW55 40227-0159 50007 Stable Base SBW55 40228-0152 50007 Stable Base SBW55 40303-0153 50007 Stable Base SBW55 40304-0154 50007 Stable Base SBW55 40304-0155 50007 Stable Base SBW55 40305-0156 Page 1 of 4 50007 Stable Base SBW55 40306-0157 50007 Stable Base SBW55 40307-0158 50007 Stable Base SBW55 40310-0159 50007 Stable Base SBW55 40311-0151 50007 Stable Base SBW55 40422-0328 50007 Stable Base SBW55 40428-0329 50007 Stable Base SBW55 40430-0321 50007 Stable Base SBW55 40505-0322 50007 Stable Base SBW55 40508-0323 50007 Stable Base SBW55 40512-0324 50007 Stable Base SBW55 40616-0152 50007 Stable Base SBW55 40618-0153 50007 Stable Base SBW55 40623-0154 50007 Stable Base SBW55 40625-0155 50007 Stable…
FDA’s list runs to 10,398 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.
Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.
The states and territories these words name
- Florida
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 2, 2015.
- FDA classified it on Nov 18, 2015.
- FDA’s Enforcement Report published it on Nov 25, 2015.
- FDA terminated it on Nov 21, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Leonhard Lang Medizintechnik GmbH, of Innsbruck, Austria.
- 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 10,398 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.