Recall archive / FDA device enforcement
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be ... — FDA record Z-0333-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 25, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
- Classification
- Class II
- Recalling firm
- Northgate Technologies, Inc.
- Quantity
- 2,277 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0333-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 23414DED, 23417DED, 23418DED; 23421DED to 23431DED; 23433DED to 23435DED; 23442DED to 23471DED 23472HED to 23519HED 23520IED to 23567IED 23568KED to 23615KED 23616AFD to 23627AFD 23628AFD to 23663AFD 23664CFE to 23711CFE 23712DFE to 23759DFE 23760EFE to 23807EFE 23808GFE to 23855GFE 23856HFE to 23867HFE 23868IFE to 23879IFE 23880IFE to 23894IFE; 23896IFE to 23899IFE; 23902IFE to 23904IFE; 23907IFE, 23908IFE GTIN 00817183020493, UDI 00817183020493. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to state of MA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 15, 2021
- Recall initiation date
- Oct 25, 2021
- Center classification date
- Dec 3, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.