Sterility and contamination recalls
Sterility recalls cover injectable medication, surgical and wound-care supplies and the equipment used with them. A breach of sterility does not mean anyone was harmed; it means the product can no longer be assumed safe for its use, so the notice usually asks clinicians and distributors to quarantine remaining stock.
3,092 stored notices, reported between Jun 20, 2012 and Nov 18, 2026. Newest first.
Reported Sep 25, 2013
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northern New England Compounding Pharmacy LLC
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beacon Hill Medical Pharmacy, P.C.
85 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2013
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Creative Compounds
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
FDA (openFDA device enforcement)
Reported Sep 18, 2013
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmacy Creations
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.South Coast Specialty Compounding, Inc.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.University Compounding Pharmacy
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wellness Pharmacy, Inc.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 11, 2013
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroAire Surgical Instruments, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2013
Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Potters Fine Foods, LLC
FDA (openFDA food enforcement)
Reported Sep 11, 2013
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stelkast Co.
FDA (openFDA device enforcement)
Reported Sep 11, 2013
1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Terrafina
1 more product in this recall
FDA (openFDA food enforcement)
Reported Sep 11, 2013
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
FDA (openFDA drug enforcement)
Reported Sep 4, 2013
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clinical Specialties Compounding Pharmacy
FDA (openFDA drug enforcement)
Reported Sep 4, 2013
Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Custom Co-Pak, LLC
1 more product in this recall
FDA (openFDA food enforcement)
Reported Sep 4, 2013
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira, Inc.
FDA (openFDA drug enforcement)
Reported Aug 28, 2013
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aspen Surgical Products, Inc.
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Belt Technologies MN
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Earthlabs, Inc. dba Wise Woman Herbals
FDA (openFDA drug enforcement)
Reported Aug 28, 2013
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
FDA (openFDA drug enforcement)
Reported Aug 21, 2013
Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pallimed Solutions
24 more products in this recall
FDA (openFDA drug enforcement)
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