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Boston Scientific Neuromodulation Corporation

Boston Scientific Neuromodulation Corporation Recalls

All product recalls associated with Boston Scientific Neuromodulation Corporation.

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

25

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 1821–1840 of 7756 recalls

Boston Scientific Neuromodulation Corporation: Superion Indirect Decompression System (IDS) Model Numbe...

Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

FDAOct 12, 2022Nationwide• Boston Scientific Neuromodulation Corporation

Becton Dickinson Infusion Therapy Systems Inc.: BD Nexiva Closed IV Catheter System - Single Port REF 383...

During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

FDAOct 12, 2022FL, GA, IL +10 more• Becton Dickinson Infusion Therapy Systems Inc.

Boston Scientific Corporation: ORISE Gel Syringe Submucosal Lifting Agent Kits: indicate...

***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

1...90 919293 94...388

Page 92 of 388Next

FDAOct 10, 2022Nationwide• Boston Scientific Corporation

2023 WABASH NATIONAL RFALHSA Recall: STRUCTURE:BODY:HATCHBACK/LIFTGATE

Wabash National Corporation (Wabash) is recalling certain 2020-2023 RFALHSA trailers. The lift gate obscures the rear conspicuity tape placed at deck height. As such, these vehicles fail to comply with the requirements of the Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSAOct 10, 2022Nationwide• WABASH NATIONAL

Boston Scientific Corporation: ORISE ProKnife Procedure Kits: indicated for use in gastr...

***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

FDAOct 10, 2022Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: ORISE Gel Submucosal Lifting Agent--Indicated for use in ...

***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

FDAOct 10, 2022Nationwide• Boston Scientific Corporation

Papaverine Phentolamine Injection (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Acetylcysteine Ophthalmic Solution (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Papaverine/Phentolamine/Prostaglandin (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Talc Sterile Powder (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Laureth-9 Injection (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Pap/Phen/Prostag/Atropine Injection (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Voriconazole Ophthalmic Solution (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Medroxyprogesterone Acetate (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Papaverine HCL Stock Solution (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Papaverine Phentolamine Injection (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Serum Tears Ophthalmic Solution (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Moxifloxacin Preservative Free (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Pred Acetate Gatifloxacin Suspension (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Brilliant Blue G (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder