Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Onkos Surgical, Inc.

Onkos Surgical, Inc. Recalls

All product recalls associated with Onkos Surgical, Inc..

Get alerts for this brand

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 621–640 of 21319 recalls

Eleos Limb Salvage System (Onkos Surgical) – Unknown Substance (2025)

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Moderate

FDAJul 11, 2025Nationwide• Onkos Surgical, Inc.

BritePro Solo Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

Moderate

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Plum Duo Infusion System (ICU Medical) – Interface Problem (2025)

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Moderate

FDA

1...30 313233 34...1066

Page 32 of 1066Next

Jul 11, 2025

Nationwide

• ICU Medical, Inc.

Britepro Solo Stubby Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

Moderate

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Microbore Extension Set (B.Braun) – Labeling Inaccuracy (2025)

Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

Low

FDAJul 9, 2025AZ, CA, CO +29 more• B BRAUN MEDICAL INC

VITROS Chemistry Ca Slides (Ortho-Clinical) – Calibration Error (2025)

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Moderate

FDAJul 9, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

High

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

Low

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Low

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Carotid WALLSTENT (Boston Scientific) – Insertion Resistance (2025)

Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.

High

FDAJul 7, 2025Nationwide• Boston Scientific Corporation

epoc BGEM BUN Test Card (Siemens) – Sodium Bias (2025)

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

Moderate

FDAJul 7, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Orascoptic Superior Visualization (Orascoptic) – Nickel Allergy Risk (2025)

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Moderate

FDAJul 3, 2025Nationwide• Orascoptic Surgical Acuity

GE OEC 9800 (GE Medical Systems) – Regulatory Non-Conformance (2025)

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

Moderate

FDAJul 2, 2025Nationwide• GE Medical Systems, LLC

Sparrow Ascent Patient Controller (Spark Biomedical) – Cable Disconnect (2025)

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

Moderate

FDAJul 2, 2025Nationwide• Spark Biomedical Inc

Activated Almonds (SunBiotics) – Salmonella Contamination (2025)

Salmonella

Salmonella Contamination. Firm detected salmonella on one batch of our SunBiotics Oat Milk Chocolate Covered Almonds.

Class IHigh

FDAJul 2, 2025AK, CA, CO +4 more• WINDY CITY ORGANICS LLC

Smoked Gouda (Boar's Head) – Mislabeling (2025)

Mislabeling

Class IIILow

FDAJul 2, 2025FL• Alpine Slicing and Cheese Conversion Company

Amlodipine Benazepril Capsules (Lupin) – Incorrect Expiration (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Class IIModerate

FDAJul 2, 2025Nationwide• Lupin Pharmaceuticals Inc.

GE OEC 9900 Elite C-arm Systems (GE Medical Systems) – Non-Conformance (2025)

Moderate

FDAJul 2, 2025Nationwide• GE Medical Systems, LLC

Robotic/Laparoscopy Kit (Carefree Surgical) – Sterility Compromise (2025)

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Low

FDAJul 1, 2025Nationwide• Carefree Surgical Specialties

Junctional Emergency Treatment Tool (North American Rescue) – Manufacturing Defect (2025)

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

Low

FDAJul 1, 2025Nationwide• North American Rescue LLC.