Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter
Medical device recall Z-0333-2022. Published in FDA’s Enforcement Report on Dec 15, 2021.
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 Dec 15, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Massachusetts the one state its words name
- 2,277 devices 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?
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
2,277 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All serial number revisions for the following bracketed base serial numbers distributed between 2/14/2017 and 10/7/2021: 21578LAA to 21627LAA 21628BBA to 21662BBA 21667CBA to 21689CBA; 21691CBA to 21697CBA; 21699CBA to 21716CBA 21690CBA,…
Every code shown here, 1,995 characters
All serial number revisions for the following bracketed base serial numbers distributed between 2/14/2017 and 10/7/2021: 21578LAA to 21627LAA 21628BBA to 21662BBA 21667CBA to 21689CBA; 21691CBA to 21697CBA; 21699CBA to 21716CBA 21690CBA, 21698CBA, 21721DBA to 21732DBA; 21734DBA to 21747DBA; 21749DBA to 21756DBA; 21758DBA to 21763DBA; 21765DBA to 21770DBA 21733DBA, 21748DBA, 21757DBA, 21764DBA, 21771EBA to 21781EBA; 21783EBA to 21787EBA; 21789EBA, 21790EBA, 21792EBA to 21800EBA; 21804EBA to 21820EBA 21782EBA, 21788EBA, 21791EBA, 21801EBA to 21803EBA; 21821FBA to 21874FBA 21883HBB to 21942HBB 21954IBB to 22025IBB 22026IBB to 22073IBB 22074IBB to 22130KBB; 22133KBB 22131KBB 22134LBB to 22157LBB 22158ACB to 22229ACB 22230ACB to 22249ACB 22250BCB to 22321BCB 22322CCB to 22393CCB 22394CCB to 22441CCB 22453ECB to 22476ECB 22477FCB to 22488FCB 22489GCB to 22500GCB 22511HCB to 22534HCB 22535ICB to 22558ICB 22559JCB to 22564JCB; 22570JCB to 22575JCB 22566JCB to 22569JCB; 22576JCB, 22577JCB, 22579JCB, 22581JCB to 22585JCB 22565JCB, 22578JCB, 22580JCB, 22586JCB to 22588JCB; 22590JCB to 22593JCB; 22595JCB, 22598JCB 22597JCB, 22600JCB to 22603JCB; 22607JCB to 22609JCB; 22611JCB, 22614JCB, 22615JCB, 22623JCB 22589JCB, 22594JCB, 22596JCB, 22599JCB, 22604JCB, 22606JCB, 22610JCB, 22612JCB, 22613JCB, 22616JCB to 22618JCB 22605JCB, 22619JCB to 22622JCB; 22624JCB to 22630JCB 22637KCB, 22638KCB, 22640KCB to 22666KCB; 22669KCB, 22671KCB to 22637KCB; 22677KCB, 22678KCB, 22680KCB 22636KCB, 22639KCB, 22639KCB to 22668KCB; 22670KCB to 22676KCB; 22679KCB, 22681KCB to 22707KCB 22632KCC to 22635KCC; 22708LCC to 22751LCC 22752ADC to 22799ADC 22800BDC to 22895BDC 22896CDC to 22943CDC 22944EDC to 22991EDC 22992FDC to 23039FDC 23040GDC to 23087GDC 23088IDD to 23135IDD 23136JDD to 23183JDD 23184KDD to 23231KDD 23232LDD to 23279LDD 23280AED to 23327AED 23328CED to 23375CED 23376DED to 23406DED; 23408DED to 23413DED; 23415DED, 23416DED, 23419DED, 23420DED, 23432DED, 23436DED to 23441DED 23407DED,…
FDA’s list runs to 2,446 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.
US Distribution to state of MA.
The states and territories these words name
- Massachusetts
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 25, 2021.
- FDA classified it on Dec 3, 2021.
- FDA’s Enforcement Report published it on Dec 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Northgate Technologies, Inc., of Elgin, IL.
- 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 2,446 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
-
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.