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Diagnostica Stago, Inc.

Diagnostica Stago, Inc. Recalls

All product recalls associated with Diagnostica Stago, Inc..

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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 4401–4420 of 21320 recalls

STA R Max Instrument (Diagnostica Stago) – coagulation time issue (2023)

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

Moderate

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

BD Kiestra InoqulA+ (Becton Dickinson) – plate visibility issue (2023)

Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+" solution is indicated for use in the clinical laboratory.

Moderate

FDAMar 22, 2023Nationwide• Becton Dickinson & Co.

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Plum 360 Replacement Battery (ICU Medical) – early capacity loss (2023)

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Moderate

FDAMar 22, 2023Nationwide• ICU Medical Inc

STA Compact Max Analyzer (Diagnostica Stago) – coagulation time issue (2023)

Moderate

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Natural Pak Bacon Glaze (Victoria Gourmet) – Mislabeled Product (2023)

Undeclared Allergen

Package actually contains "Coffee Chili Rub" resulting in sea salt, ancho chile, espresso beans, mustard, coriander, ginger, oregano, chipotle chile being undeclared on the label

Class IIILow

FDAMar 22, 2023OH• Victoria Gourmet, Inc.

ASM Replacement Battery (ICU Medical) – early capacity loss (2023)

Low

FDAMar 22, 2023Nationwide• ICU Medical Inc

Coffee Chili Rub (Victoria Gourmet) – Undeclared Ingredients (2023)

Undeclared Allergen

Package contains "Bacon Glaze" resulting in: demerara sugar, honey granules, maple sugar, cinnamon, all spice, clove, parsley being undeclared on the label

Class IIILow

FDAMar 22, 2023OH• Victoria Gourmet, Inc.

ARTIS One Angiography System (Siemens) – monitor display issue (2023)

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

Moderate

FDAMar 21, 2023Nationwide• Siemens Medical Solutions USA, Inc

Philips Azurion System (Philips) – X-ray functionality loss (2023)

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Moderate

FDAMar 21, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

COBRA-OS Sheath Introducer (Merit Medical) – incorrect needle size (2023)

Custom sheath Introducer contains incorrect needle size

Low

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

Philips Incisive CT System (Philips) – foot switch entrapment (2023)

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

Moderate

FDAMar 20, 2023Nationwide• Philips North America

Spectral CT 7500 System (Philips) – foot switch entrapment (2023)

Laceration Risk

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

High

FDAMar 17, 2023Nationwide• Philips North America Llc

Medtronic SenSight Tunneler Kit (Medtronic) – carrier machining issue (2023)

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

Moderate

FDAMar 17, 2023Nationwide• Medtronic Neuromodulation

Magnesium Citrate Powder (Jost Chemical) – Microbial Count Issue (2023)

Dietary ingredient had a Total Aerobic Microbial Count (TAMC) above firm's specification.

Class IIILow

FDAMar 17, 2023FL• Jost Chemical Co

Glimepiride 4mg Tablets (Amerisource) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAMar 17, 2023Nationwide• Amerisource Health Services LLC

Glimepiride Tablets (Amerisource Health Services) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAMar 17, 2023Nationwide• Amerisource Health Services LLC

Glimepiride Tablets (Amerisource Health Services) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAMar 17, 2023Nationwide• Amerisource Health Services LLC

Nurtec ODT (Pfizer) – Packaging Safety Issue (2023)

This recall involves prescription drugs Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of 8 tablets. The tablets are in a non-child resistant blister card packaged in a carton that includes the name of the product, dosage strength, expiration date. The dosage strength and expiration date are printed or stamped on the blister card. The recall includes the following: Product Description NDC Number Expiration Date Nurtec® ODT (rimegepant) 75mg 8-Unit Dose blister pack 72618-3000-2 All dates through 6/2026

Low

CPSCMar 16, 2023Nationwide• Biohaven Pharmaceuticals Inc., of New Haven, Conn.

Atellica IM Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Moderate

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Fredericksburg Candles – Laceration Risk (2023)

Laceration Risk

This recall involves 10-ounce Scented Candles in a square glass jar with a glass lid. The model number and UPC code are printed on the label on the bottom of the jar. Fredericksburg Farms is printed on the front of the jar The following 15 scents of candles are included in the recall: The bag containing potassium hydroxide has a blue label with "POTASSIUM HYDROXIDE FLAKES." Model # Scent UPC Code D2001A West Texas Saddle Leather, 10 oz. 8 00565 80822 2 D2009A Buttery Vanilla, 10 oz. 8 00565 80826 0 D2011A Creme Brulee, 10 oz. (Small) 8 00565 80828 4 D2012A Spiced Orange, 10 oz. (Small) 8 00565 80830 7 D2013A Hill Country Christmas, 10 oz. (Small) 8 00565 80832 1 D2017A Bird of Paradise, 10 oz. (Small) 8 00565 80834 5 D2025A Hill Country Lavender, 10 oz. (Small) 8 00565 80840 6 D2042A Sandalwood Currant, 10 oz. (Small) 8 00565 80854 3 D3100A Texas Ruby Red Grapefruit, 10 oz. (Small) 8 00565 80856 7 D3101A Autumn Harvest, 10 o. 8 00565 80858 1 D3111A Spiced Chestnut, 10 oz. (Small) 8 00565 80876 5 D3112A Snowy Mountain Lodge, 10 oz. (Small) 8 00565 80877 2 D3113A Peppercorn & Ginger, 10 oz. (Small) 8 00565 80878 9 D3115A Teakwood & Mahogany, 10 oz. (Small) 8 00565 80880 2 D3116A Vanilla Birch, 10 oz. (Small) 8 00565 80881 9

High

CPSCMar 16, 2023Nationwide• Fredericksburg Distribution, dba Fredericksburg Farms, of Fredericksburg, Texas