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Acrobat SUV Stabilizer (Maquet) – Sterile Barrier Compromise (2024)

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

High

FDAOct 16, 2024Nationwide• Maquet Cardiovascular, LLC

Hatch Chile Chicken Enchiladas (Sam's Club) – Listeria Risk (2024)

Listeria

Presence of Listeria monocytogenes

Class IIModerate

FDAOct 16, 2024Nationwide• Sam'S Club

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Acrobat SUV Stabilizer (Maquet) – Sterile Barrier Compromise (2024)

Hatch Chile Chicken Enchiladas (Sam's Club) – Listeria Risk (2024)

Medline Shoulder Repair Pack (Medline) – Incorrect Suture Package (2024)

Alcon Custom-Pak Constellation (Alcon) – Tubing Breakage (2024)

Draeger Atlan Anesthesia Workstation (Draeger) – Ventilation Failure (2024)

Tandem Bipolar Shell (Smith & Nephew) – Retaining Ring Size (2024)

Medline Open Heart CDS (Medline) – Incorrect Suture Package (2024)

OrganOx Metra (Unknown) – Battery Cell Damage (2024)

Medline Pacer Implant Pack (Medline) – Incorrect Suture Package (2024)

Organic Salsa (Glaser Farms) – Glass Contamination (2024)

OneLAX Docusate Sodium (Akron) – CGMP Deviation (2024)

Defibtech Adult Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Defibtech Adult Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Defibtech Pediatric Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Defibtech Pediatric Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Cook CTO Micro Wire Guide (Cook) – Incorrect Expiration Date (2024)

Peppermint Mocha Zero Sugar (International Delight) – Mislabeled Sugar (2024)

Welch Allyn Cardiology Suite (Baxter) – File ID Duplication (2024)

Welch Allyn RScribe ECG System (Baxter) – File ID Duplication (2024)

Welch Allyn XScribe System (Baxter) – File ID Duplication (2024)