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Recall archive

94,533 stored notices, from Jun 20, 2012 to Oct 2, 2026.

31,892 recalls · page 395 of 1329

Medical devices

Reported Sep 21, 2022

iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration…

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

Alcor Scientific, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

BIOPHEN UFH Control Plasma

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

Aniara Diagnostica LLC

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

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

Baxter Healthcare Corporation

FDA (openFDA device enforcement)

Drugs

Reported Sep 21, 2022

L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

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

Carolina Infusion

19 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 21, 2022

FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50…

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

Carwild Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular…

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

Cook Incorporated

12 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 21, 2022

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534,…

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

Direct Rx

FDA (openFDA drug enforcement)

Drugs

Reported Sep 21, 2022

Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%,…

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

Edgewell Personal Care Brands, LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 21, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E…

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

Exactech, Inc.

9 more products in this recall

FDA (openFDA device enforcement)

Food

Reported Sep 21, 2022

Shrimp Tempura and spice shrimp roll (11.2 oz) with expiration 08/12/2022

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

EZ Noble Sushi

7 more products in this recall

FDA (openFDA food enforcement)

Medical devices

Reported Sep 21, 2022

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

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

FUJIFILM Healthcare Americas Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Food

Reported Sep 21, 2022

GNC Vitamin B-6 100mg 100 VEGETARIAN TABLETS DIETARY SUPPLEMENTS Distributed by: General Nutrition Corporation…

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

General Nutrition Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Sep 21, 2022

MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed…

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

ICU Medical, Inc.

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with…

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

Isopure Corp.

FDA (openFDA device enforcement)

Food

Reported Sep 21, 2022

Capri Sun, Wild Cherry, Flavored Juice Drink Blend in 6floz. foil pouch. Sold in carton containing 10 pouches. Carton…

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

Kraft Heinz Foods Company

FDA (openFDA food enforcement)

Drugs

Reported Sep 21, 2022

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…

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

Lupin Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 21, 2022

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery…

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

Mako Surgical Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of…

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

Mallinckrodt, LLC.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b.…

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

Microbiologics Inc.

FDA (openFDA device enforcement)

Drugs

Reported Sep 21, 2022

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further…

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

Pfizer Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 21, 2022

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

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

Philips Medical Systems (Cleveland) Inc.

FDA (openFDA device enforcement)

Drugs

Reported Sep 21, 2022

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10…

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

Pine Pharmaceuticals, LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 21, 2022

PTS Panels CHOL+GLU Test Strips (REF 1765)

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

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 21, 2022

QIAcube Connect MDx, Model No. 9003070

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

Qiagen Sciences LLC

FDA (openFDA device enforcement)

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