États-Unis Recalls

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Gifford's HomeMaine ice cream brand POWER PLAY FUDGE; ONE QUART (946 mL); UPC: 8 60864 00030 7

Potential foreign object contamination: rubber pieces

Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Devices could potentially be occluded or partially occluded.

OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Whole Foods Spicy Guacamole Dip No Tomatoes, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 25745200000, 284324000000, 23501500000, 25744900000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Devices could potentially be occluded or partially occluded.

Dentsply Sirona Capsule Mixer Model No. 5546068

Potential for electrical discharge from unit when unplugged.

Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Potential for arterial sheath tip separation or partial tip separation during use.

Whole Foods Salsa, Heirloom Tomato. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Jalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged in assorted bulk package sizes (10lbs, 40lbs, 35lbs, 20lbs, 38lbs 1 1/9 Bushel) ; Product of MX; Coast Tropical TX UPCs 73296608113; 73296600558; 73296610927; 73296600559; 732966107055; 02060042710

Potential Salmonella Javiana contamination

Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Get Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box

Potential Salmonella contamination

Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21212000000, 21211900000, 25138200000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Revival Animal Health, LLC Voluntarily Recalls Feline Milk Replacers Due to Inconsistent Levels of Vitamins and Trace Minerals

Whole Foods Mild Guacamole Dip No Tomatoes, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 24293900000, 25745000000, 24367500000, 25658600000, Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

Whole Foods Mild Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.