Boston Scientific Corporation: 296 recalls on record

Recalls filed with 1 agency: FDA (296).

First recall on record: June 27, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 73 · Class II: 221 · Class III: 2

Most recent recalls

DateAgencyProduct
January 22, 2014FDABoston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN…Z-0711-2014
January 22, 2014FDATWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Produc…Z-0719-2014
January 22, 2014FDATWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product…Z-0720-2014
January 22, 2014FDABoston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UP…Z-0712-2014
January 22, 2014FDATWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Produc…Z-0723-2014
January 22, 2014FDATWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Produc…Z-0722-2014
December 11, 2013FDANavigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catal…Z-0441-2014
December 11, 2013FDANavigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catal…Z-0442-2014
December 11, 2013FDANavigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Cata…Z-0440-2014
September 11, 2013FDABoston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: …Z-2137-2013
September 11, 2013FDABoston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.…Z-2138-2013
July 24, 2013FDAAlair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M0…Z-1748-2013
July 17, 2013FDARigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Pr…Z-1671-2013
July 17, 2013FDANephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M00…Z-1672-2013
July 17, 2013FDANephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number…Z-1673-2013
October 24, 2012FDALeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), …Z-0079-2013
October 24, 2012FDALeveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, elect…Z-0080-2013
October 24, 2012FDALeveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intend…Z-0081-2013
June 27, 2012FDABoston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner…Z-1850-2012
June 27, 2012FDABoston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inne…Z-1852-2012
June 27, 2012FDABoston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inne…Z-1851-2012

Questions about this company

How many recalls does Boston Scientific Corporation have?
Recalert has 296 U.S. recalls on record for Boston Scientific Corporation, published between June 27, 2012 and September 23, 2026.
Which agencies have handled Boston Scientific Corporation recalls?
Boston Scientific Corporation appears as the recalling firm in recalls from: FDA (296).

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