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Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston Recalls

All product recalls associated with Boston Scientific Corporation One Boston.

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Recall Summary

Total Recalls

1000

Past Year

566

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 6581–6600 of 7756 recalls

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 Guide Catheter 6F, IM Internal M...

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 peripheral Guide Catheter 6F, H...

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated...

Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

FDA

1...328 329330331 332...388

Page 330 of 388Next

Jan 24, 2008

Nationwide

• Biogenex Laboratories

California Medical Laboratories Inc: CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Si...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

California Medical Laboratories Inc: CalMed Malleable Pericardial Sump, Single Use Only. Do No...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

Serene Float Tanks (Brian Smith) – electrocution hazard (2008)

Laceration Risk

This recall involves Serene Float Tanks, a water tank that is light- and soundproof, temperature insulated and ventilated. The heated tanks are filled with water and a dissolvent that allows a person to float effortlessly.

CPSCJan 24, 2008Nationwide• Brian Smith, dba Serene Float Tanks, of Lakewood, Calif.

B & K Medical Systems, Inc.: B-K Medical Intraoperative Transducer Type 8814, diagnost...

Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

FDAJan 24, 2008MA, MI, OR +2 more• B & K Medical Systems, Inc.

Abbott Laboratories: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; L...

Laceration Risk

Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

FDAJan 21, 2008PR• Abbott Laboratories

Abbott Laboratories: CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN ...

Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.

FDAJan 15, 2008AZ, AR, CA +27 more• Abbott Laboratories

Beckman Coulter Inc: IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) R...

IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.

FDAJan 10, 2008Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Beckman Coulter Access Immunoassay System Hybritech PSA C...

Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.

FDAJan 8, 2008Nationwide• Beckman Coulter Inc

Cannondale Scalpel Mountain Bikes – Frame Failure (2008)

The 2008 model year Scalpel is a cross-country racing mountain bike, made from carbon fiber and aluminum. They were sold in Black/White, Blue/Black and Black. The recall includes the following models: Model # Product Retail Price 8AVPFR Scalpel Frameset about $3,200 8VPO Scalpel Team about $6,900 8VP1 Scalpel 1 about $6,400 8VP2 Scalpel 2 about $4,300 Only certain serial numbers are affected.

CPSCJan 8, 2008Nationwide• Cannondale Bicycle Corporation, of Bethel, Conn.

Beckman Coulter Inc: Beckman Coulter Access Hybritech free PSA Calibrators, RE...

Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.

FDAJan 8, 2008Nationwide• Beckman Coulter Inc

Bio-Rad Laboratories: Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In ...

Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.

FDAJan 7, 2008Nationwide• Bio-Rad Laboratories

Bayer Healthcare LLC: Bayer Contour TS blood glucose monitoring system with 10 ...

InaccurateTest Strip Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

FDADec 21, 2007Nationwide• Bayer Healthcare LLC

Bayer Healthcare LLC: Bayer Contour TS blood glucose test strips packaged in pa...

Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

FDADec 21, 2007Nationwide• Bayer Healthcare LLC

Abbott Laboratories: White Blood Cell (WBC) Reagent-Part A used with the CELL-...

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

FDADec 19, 2007AL, AK, AZ +35 more• Abbott Laboratories

Ski-Doo Snowmobiles (BRP) – Crash Hazard (2007)

The recall involves Ski-Doo model year 2008 MXZ X 600 RS snowmobiles. The model name is located on the side panels. The snowmobiles were sold in yellow or black/slate.

CPSCDec 19, 2007Nationwide• Bombardier Recreational Products Inc. (BRP), of Quebec, Canada

Viasys Respiratory Care, Inc.dba Bird Products: VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Co...

Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

FDADec 17, 2007AL, CA, MA +3 more• Viasys Respiratory Care, Inc.dba Bird Products

Billy Goat MultiVac Outdoor Vacuums (Billy Goat) – fire hazard (2007)

Fire/Burn Risk

The recalled outdoor vacuum is black and green with a red motor housing. "Billy Goat" is printed on the vacuum's bag. Only outdoor vacuums with the following model and serial numbers are included in the recall. The model and serial numbers are printed on a label located directly below the height adjustment crank on the left side of the vacuum. Models MV650H MV650SPH Serial Numbers 061107xxx 061807xxx 062507xxx 070907xxx 072407xxx 073007xxx 080607xxx 081307xxx 082007xxx 082707xxx 090407xxx 091007xxx

CPSCDec 12, 2007Nationwide• Billy Goat Industries Inc, of Lee's Summit, Mo.