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Universal Meditech Inc.

Universal Meditech Inc. Recalls

All product recalls associated with Universal Meditech Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 5101–5120 of 25000 recalls

SARS-CoV-2 Test Kit (Universal Meditech) – Unauthorized Distribution (2022)

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Low

FDANov 28, 2022Nationwide• Universal Meditech Inc.

Sodium Bicarbonate Injection (Exela) – Defective Container (2022)

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Class IHigh

FDANov 28, 2022Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela) – Defective Container (2022)

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Class I

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High

FDANov 28, 2022Nationwide• Exela Pharma Sciences LLC

Sodium Chloride Injection (B. Braun) – Potential Leakage (2022)

Lack of sterility assurance: Bags have the potential to leak.

Class IIModerate

FDANov 25, 2022FL, NJ, PA• B. Braun Medical, Inc.

Papa Bear and Mama Bear Mugs (Indigo) - Burn and Laceration Hazard (2022)

Fire/Burn Risk

This recall involves Indigo branded Papa Bear and Mama Bear mugs with batch numbers 1220, 0621, 1021or 0920. Indigo and the batch number are printed on the bottom of the mugs. The UPC number 882709402770 or 882709402763 is printed on a white price sticker on the bottom of the mugs. The mugs are made of ceramic and have a white exterior with either a "PAPA BEAR" or "MAMA BEAR" decal and white animal ears on the rim. The interior of the Papa Bear mug is blue and the interior of the Mama Bear mug is aqua. Indigo is printed on the bottom of the mugs.

Moderate

CPSCNov 23, 2022Nationwide• Guangdong Totye, Ceramics, of Chaozhou, China

Desmopressin Acetate Tablets (Heritage) – Subpotent Drug (2022)

Subpotent Drug

Class IIModerate

FDANov 23, 2022Nationwide• Heritage Pharmaceuticals Inc

Weis Quality Sea Salt Caramel Ice Cream (Weis) - Undeclared Soy and Coconut (2022)

Undeclared Soy

Undeclared soy and coconut

Class IIModerate

FDANov 23, 2022DE, IN, MD +5 more• Weis Markets, Inc., Ice Cream Division

Ingenia Elition S MR System (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

Alinity m Resp-4-Plex Kit (Abbott) – False Result Risk (2022)

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Moderate

FDANov 22, 2022Nationwide• Abbott Molecular, Inc.

Ingenia Elition X MR System (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

MR 7700 System Upgrade (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

MR 7700 System (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

SmartPath to Elition X (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

Specific Protein Control (Randox) – Rheumatoid Factor Decrease (2022)

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Moderate

FDANov 22, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

XO Marshmallow Banana Puddin' (XO Marshmallow) - No Product Label (2022)

No label on packaged product

Class IIModerate

FDANov 22, 2022AL, AR, CA +24 more• XO Marshmallow, LLC

Proveo 8 Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Fetal Spiral Electrode (Philips) – Tip Breaking Risk (2022)

Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

High

FDANov 21, 2022Nationwide• Philips North America Llc

Provido Microscope (Leica) – Power Supply Overheat (2022)

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

Moderate

FDANov 18, 2022Nationwide• Ventana Medical Systems, Inc.