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Spectranetics Corporation

Spectranetics Corporation Recalls

All product recalls associated with Spectranetics Corporation.

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Recall Summary

Total Recalls

1000

Past Year

1000

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 4901–4920 of 21320 recalls

Philips Laser System (Spectranetics) – System Failure Risk (2022)

Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.

Moderate

FDAOct 14, 2022AZ, AR, CA +27 more• Spectranetics Corporation

VITROS Chemistry Calibrator (Ortho-Clinical) – Calibration Mathematics Issue (2022)

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

Moderate

FDAOct 13, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

EKOS Control Unit (Boston Scientific) – Instructions Mismatch (2022)

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

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Moderate

FDAOct 13, 2022CA, IL, KY +4 more• Boston Scientific Corporation

BD Phoenix PMIC/ID Panel (Becton Dickinson) – Antibiotic Test Issue (2022)

Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

Moderate

FDAOct 13, 2022Nationwide• Becton Dickinson & Co.

Superion Decompression System (Boston Scientific) – Weld Breakage Risk (2022)

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.

Moderate

FDAOct 12, 2022Nationwide• Boston Scientific Neuromodulation Corporation

Basin Set (American Contract) – Labeling Mismatch (2022)

Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.

Low

FDAOct 12, 2022Nationwide• American Contract Systems, Inc.

BD Nexiva IV Catheter (Becton Dickinson) – Shield Separation Risk (2022)

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).

Moderate

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

Disposable Instrument Pack (Medical Action) – Debris Contamination (2022)

Scissors contained debris.

Moderate

FDAOct 12, 2022FL, IL, IN +5 more• Medical Action Industries, Inc.

Port Access Kit (Medical Action) – Incorrect Label Placement (2022)

The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.

Moderate

FDAOct 12, 2022MN• Medical Action Industries, Inc.

Nestle Chocolate Chip Cookie Dough – Plastic Contamination (2022)

Consumer complaints reported presence of white pieces of plastic in cookie product.

Class IIModerate

FDAOct 12, 2022AL, AZ, AR +37 more• Nestle-USA, Inc. (Corporate Office)

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDAOct 11, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

PAJUNK Epidural Tray (Pajunk) – Medication Labeling Error (2022)

The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

Moderate

FDAOct 10, 2022Nationwide• Pajunk Medical Systems, L.P.

ORISE Gel Syringe Kit (Boston Scientific) – Foreign Body Risk (2022)

***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

Moderate

FDAOct 10, 2022Nationwide• Boston Scientific Corporation

Medfusion 4000 Pump (Smiths Medical) – Infusion Message Delay (2022)

Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

Moderate

FDAOct 10, 2022IN, TX, VA• Smiths Medical ASD Inc.