The Fierro Group Inc. dba Rico Brands Recalls

FDAFeb 7, 2024UT• The Fierro Group Inc. dba Rico Brands

Firm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.

Class IHigh

Chicken Enchilada Mole (Rico Brands) – Listeria Risk (2024)

FDAFeb 7, 2024UT• The Fierro Group Inc. dba Rico Brands

Firm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.

Class IHigh

Cheese Enchiladas Green Sauce (Rico Brands) – Listeria Risk (2024)

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Firm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.

Class IHigh

FDAFeb 7, 2024UT• The Fierro Group Inc. dba Rico Brands

Cheese Enchiladas Red Sauce (Rico Brands) – Listeria Risk (2024)

FDAFeb 7, 2024UT• The Fierro Group Inc. dba Rico Brands

Firm is recalling enchiladas made with Queso Fresno cheese due to the potential contamination with Listeria monocytogenes.

Class IHigh

Azurion 3 (Philips) – Generator Failure Risk (2024)

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 5 (Philips) – Generator Failure Risk (2024)

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 (Philips) – Generator Failure Risk (2024)

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Cerebase DA Guide Sheath (Medos) – Fracture Risk (2024)

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

FDAFeb 2, 2024Nationwide• Medos International Sarl Chemin Blanc 36 Le Locle Switzerland

Meta Psyllium Fiber Capsules (Procter & Gamble) – Illegible Label (2024)

Illegible Label

Class IIModerate

FDAFeb 1, 2024AL, AZ, AR +38 more• The Procter & Gamble Company

Coffee Bags (House of Coffee Beans) – Allergen Contact (2024)

potential allergen contact with almonds, pecans and coconut.

Class IIModerate

FDAFeb 1, 2024Nationwide• House of Coffee Beans, Inc

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

IdentiTi ALIF System (Alphatec) – Graft Bolt Breakage (2024)

Due to reports of intraoperative graft bolt implantation breakages.

FDAJan 26, 2024Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

I.B.S Compression Screw (In2Bones) – Batch Mix-up (2024)

This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

FDAJan 26, 2024Nationwide• In2Bones, SAS 28 Chemin du petit Bois Ecully France

Impression Coping (Thommen) – Canal Depth Issue (2024)

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

FDAJan 24, 2024Nationwide• Thommen Medical AG Eschenweg 3 Bettlach Switzerland

Adrenalin Epinephrine Injection (Henry Schein) – Incorrect Labeling (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Class IIModerate

FDAJan 17, 2024Nationwide• Henry Schein Inc. and Glove Club HSI Gloves Inc.

W&H Surgical Handpiece (W&H) – Laser Marking Error (2024)

1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

FDAJan 16, 2024Nationwide• W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria

Directional Laser Probe (D.O.R.C.) – Fiber Extension Problem (2024)

When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

FDAJan 15, 2024Nationwide• D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands

3M Specialty Blade Assembly (3M) – Burn Risk (2024)

Fire/Burn Risk

3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)."

FDAJan 12, 2024Nationwide• 3M Company Health Care Business 3m Center

Custodiol HTK Solution (Dr. Franz Koehler) – Particle Presence (2024)

Potential for particles to be present in solution.

FDAJan 9, 2024Nationwide• Dr Franz Koehler Chemie Gmbh Werner-Von-Siemens-Str. 14-28 Bensheim Germany

Allura Xper X-ray Systems (Philips) – Framegrabber Performance Issue (2024)

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.