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Abbott Molecular, Inc.

Abbott Molecular, Inc. Recalls

All product recalls associated with Abbott Molecular, 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 1121–1140 of 25000 recalls

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

Low

FDAMar 20, 2025Nationwide• Abbott Molecular, Inc.

Cerene Cryotherapy Device (Channel Medsystems) – gasket seal issue (2025)

Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device

Moderate

FDAMar 20, 2025Nationwide• Channel Medsystems, Inc.

Quantum Informatics VIPER (Spectrum Medical) – FDA clearance (2025)

Medical device software marketed without FDA clearance .

Low

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FDA

Mar 19, 2025

AL, AZ, AR +35 more

• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Ballard Closed Suction Catheters (Avanos) – sterility concern (2025)

Lack of sterility assurance for closed suction catheter systems

High

FDAMar 19, 2025Nationwide• Avanos Medical, Inc.

Brioche Bread and Buns (Baking Group) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (soy, milk) and Yellow #5

Class IIModerate

FDAMar 19, 2025TX• Harvey Investments LLC / The Baking Group

Turkey BLT on Sourdough (Hearn Kirkwood) – Incorrect Sandwich (2025)

Undeclared Allergen

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

Class IIModerate

FDAMar 19, 2025NY• The Coastal Companies DBA Hearn Kirkwood

Apple Juice (Martinelli) – Potential Contamination (2025)

Potential contamination with patulin.

Class IIModerate

FDAMar 18, 2025AL, AZ, AR +25 more• S Martinelli & Company

Gold Garlic Powder (Pacific Meridian) – Metal Contamination (2025)

Potential contamination with foreign objects (metal)

Class IIModerate

FDAMar 17, 2025CA, IL, TX• Pacific Meridian Group, LLC

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Failed dissolution specifications: lower than specifications

Class IIModerate

FDAMar 17, 2025Nationwide• BIOCON PHARMA INC

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Low

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

Jinga Glass Noodles (HAR Maspeth) – Undeclared Egg (2025)

Undeclared Egg

Contains undeclared egg

Class IHigh

FDAMar 14, 2025CT, GA, IL +7 more• HAR Maspeth Corp.

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Low

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

DORO Easy-Connect Navigator (Pro-Med) – reference array issue (2025)

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

Moderate

FDAMar 14, 2025Nationwide• Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany