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Recall archive

94,914 stored notices, from Jun 20, 2012 to Oct 21, 2026.

32,165 recalls · page 494 of 1341

Medical devices

Reported Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Cardinal Health

2 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 1, 2021

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Custopharm, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 1, 2021

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

DePuy Orthopaedics, Inc.

FDA (openFDA device enforcement)

Consumer products

Reported Sep 1, 2021

SKE Outdoors Recalls Kids Bike Helmets Due to Risk of Head Injury

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Dongguan Flying Sports Goods Co. Ltd.

CPSC

Drugs

Reported Sep 1, 2021

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Eli Lilly & Company

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 1, 2021

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Encore Medical, LP

FDA (openFDA device enforcement)

Medical devices

Reported Sep 1, 2021

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Ethicon Endo-Surgery Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Food

Reported Sep 1, 2021

Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Frito-Lay, Inc. Headquarters

FDA (openFDA food enforcement)

Drugs

Reported Sep 1, 2021

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Hikma Pharmaceuticals USA Inc.

FDA (openFDA drug enforcement)

Food

Reported Sep 1, 2021

Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 mL) packaged in paper cartons 75…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hiland Dairy Foods Company LLC

FDA (openFDA food enforcement)

Drugs

Reported Sep 1, 2021

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

His Enterprise Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 1, 2021

ECHELON MRI System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hitachi Healthcare Americas Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 1, 2021

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

KVK-Tech, Inc.

FDA (openFDA drug enforcement)

Food

Reported Sep 1, 2021

Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

New Dawn Nutrition, Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Sep 1, 2021

NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Northeast Scientific Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 1, 2021

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Oakworks Inc.

FDA (openFDA device enforcement)

Consumer products

Reported Sep 1, 2021

PetSmart Recalls Top Paw Double Diner Dog Bowls Due to Laceration Hazard

High riskUsing this product could cause serious injury, illness or death — stop using it now.

PetSmart Home Office Inc.

CPSC

Medical devices

Reported Sep 1, 2021

Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips North America LLC

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 1, 2021

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Procept Biorobotics Corporation

FDA (openFDA device enforcement)

Drugs

Reported Sep 1, 2021

PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc.,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Professional Disposables International, Inc.

6 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Sep 1, 2021

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

RemedyRepack Inc.

FDA (openFDA drug enforcement)

Food

Reported Sep 1, 2021

Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

RMH Foods

FDA (openFDA food enforcement)

Medical devices

Reported Sep 1, 2021

Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Roche Diabetes Care, Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 1, 2021

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

SigmaPharm Laboratories LLC

FDA (openFDA drug enforcement)

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