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Recall archive

94,528 stored notices, from Jun 20, 2012 to Oct 2, 2026.

31,892 recalls · page 382 of 1329

Medical devices

Reported Nov 23, 2022

MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

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

Canadian Hospital Specialties

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF…

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

Carefusion 2200 Inc.

16 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L,…

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

Covidien, LP

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D,…

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

DeVilbiss Healthcare LLC

FDA (openFDA device enforcement)

Food

Reported Nov 23, 2022

Gem City Fine Foods GF Flourless Chocolate Torte, 4 oz., frozen gluten free dessert, clear plastic package, UPC…

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

Gem City Fine Foods, LLC

FDA (openFDA food enforcement)

Medical devices

Reported Nov 23, 2022

Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

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

Getinge USA Sales Inc.

FDA (openFDA device enforcement)

Consumer products

Reported Nov 23, 2022

Green Sprouts Recalls Toddler's Stainless Steel Bottles and Cups Due to Lead Poisoning Hazard (Recall Alert)

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

Green Sprouts Inc.

CPSC

Consumer products

Reported Nov 23, 2022

Indigo Books & Music Recalls Indigo Branded Bear Mugs Due to Burn and Laceration Hazards

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

Guangdong Totye, Ceramics

CPSC

Medical devices

Reported Nov 23, 2022

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

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

Howmedica Osteonics Corp.

FDA (openFDA device enforcement)

Drugs

Reported Nov 23, 2022

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois,…

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

ICU Medical Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Nov 23, 2022

Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.

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

ImprimisRx NJ

FDA (openFDA drug enforcement)

Medical devices

Reported Nov 23, 2022

18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011:…

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

Insulet Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted…

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

LeMaitre Vascular, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…

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

Medtronic Navigation, Inc.

FDA (openFDA device enforcement)

Food

Reported Nov 23, 2022

Nash Family Creamery Ranch Cheese Curd packaged in 8oz plastic bag

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

Nash Cheese Co. LLC

FDA (openFDA food enforcement)

Drugs

Reported Nov 23, 2022

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street…

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

Nephron Sterile Compounding Center LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Nov 23, 2022

OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine…

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

Novapproach Spine LLC

FDA (openFDA device enforcement)

Drugs

Reported Nov 23, 2022

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut…

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

Par Formulations Private Limited

FDA (openFDA drug enforcement)

Medical devices

Reported Nov 23, 2022

GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

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

Sonendo Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular…

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

Spectranetics Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and…

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

Steris Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140…

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

Teleflex LLC

FDA (openFDA device enforcement)

Medical devices

Reported Nov 23, 2022

Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

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

Texas Medical Technology Inc.

FDA (openFDA device enforcement)

Consumer products

Reported Nov 23, 2022

Bentex Recalls Children's Clothing Sets Due to Violation of the Federal Lead Paint and Lead Content Ban; Lead Poisoning…

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

The Bentex Group

CPSC

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