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UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

UNIMAX MEDICAL SYSTEMS INC 8F-2, NO Recalls

All product recalls associated with UNIMAX MEDICAL SYSTEMS INC 8F-2, NO.

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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 2041–2060 of 21320 recalls

Tech Medical Endo Retrieval Pouch (Unimax) – Tube Fall Risk (2024)

The tube may fall into the surgical site during the grasping process.

High

FDAJun 25, 2024Nationwide• UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

NIM Vital Nerve Monitoring System (Medtronic) – False Negative Risk (2024)

Potential for false negative response on the NIM Vital Nerve Monitoring System

Moderate

FDAJun 24, 2024Nationwide• Medtronic Xomed, Inc.

Bupropion Extended-Release Tablets (Amerisource) – Dissolution Issue (2024)

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Class IIModerate

FDA

1...101 102103104 105...1066

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Jun 24, 2024

Nationwide

• Amerisource Health Services LLC

SinuFrin Nasal Decongestant (Neilmed) – Sub-Potent Drug (2024)

Sub-potent Drug

Class IIILow

FDAJun 24, 2024Nationwide• Neilmed Pharmaceuticals Inc

2021 Sea Electric Ford F59 (Sea Electric) – Battery Management Issue (2024)

SEA Electric LLC (SEA Electric) is recalling certain 2023-2025 SEA Electric 5e, 2020-2022 Ford F59, 2020 Hino 195, and 2019 Isuzu NRR vehicles equipped with certain software versions from December 2022 and earlier. The battery management system (BMS) software can cause the high-voltage battery to shut down, resulting in a loss of drive power.

Low

NHTSAJun 24, 2024Nationwide• SEA ELECTRIC

ESG-410 Electrosurgical Generator (Olympus) – Power-On Failure (2024)

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

High

FDAJun 21, 2024Nationwide• Olympus Corporation of the Americas

Venlafaxine Extended-Release Capsules (Zydus) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Class IIModerate

FDAJun 21, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Acetaminophen Tablets (A-S Medication) – Labeling Mix-Up (2024)

Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.

Class IHigh

FDAJun 21, 2024Nationwide• A-S Medication Solutions LLC

2025 IC Bus CESB (IC Bus) – Tie Rod Assembly Defect (2024)

Navistar, Inc. (Navistar) is recalling certain 2025 IC Bus CE school buses. Tie rod assemblies may contain ball studs that may have been incorrectly heat-treated, which can cause them to break, and possibly result in tie rod failure.

High

NHTSAJun 20, 2024Nationwide• IC BUS

Hendrickson Composilite (Hendrickson) – Tie Rod Ball Stud Problem (2024)

Hendrickson USA. LLC (Hendrickson) is recalling certain Composolite EXS20 steerable lift axle suspension assemblies. The tie rod assembly ball stud could have been improperly heat treated and can fail.

High

NHTSAJun 20, 2024Nationwide• HENDRICKSON

BioFire Blood Culture Panel (BioFire) – False Positive Concern (2024)

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

Moderate

FDAJun 19, 2024Nationwide• BioFire Diagnostics, LLC

UNITRAX Endoprosthesis Head (Howmedica) – Mislabeling Issue (2024)

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Low

FDAJun 19, 2024Nationwide• Howmedica Osteonics Corp.

FoundationOne CDx (Foundation Medicine) – Report Discrepancy (2024)

Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.

Low

FDAJun 18, 2024Nationwide• Foundation Medicine, Inc.

Soft-VU Kumpe 5F X 40CM (Angiodynamics) – Mislabeling Issue (2024)

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Low

FDAJun 18, 2024Nationwide• Angiodynamics, Inc.

Soft-VU Kumpe 5F X 65CM (Angiodynamics) – Mislabeling Issue (2024)

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Low

FDAJun 18, 2024Nationwide• Angiodynamics, Inc.

Venlafaxine Hydrochloride (Major Pharmaceuticals) – Dissolution Failure (2024)

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Class IIModerate

FDAJun 18, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Delflex Peritoneal Dialysis Solution (Fresenius) – Tube Weld Failure (2024)

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Class IIModerate

FDAJun 18, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Infusomat Universal Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

High

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)

High

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)

High

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.