Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

43251–43275 of 50511

HighFDA (Devices)·Z-1716-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-758-2013·2013-07-17
Methylprednisolone Injection Is Recalled Over Sterility Assurance Concerns
Olympia Pharmacy is recalling compounded methylprednisolone acetate 80 mg/mL injection, code A3104, expiring June 4, 2013, because FDA inspection findings raised concerns about quality control and sterility assurance. The product was distributed nationwide and in Puerto Rico.
Product
Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1646-2013·2013-07-17
Archer Farms Smoked Salmon Dip Recalled for Undeclared Fish and Egg Allergens
Garden Fresh Foods is recalling Archer Farms Smoked Salmon Dip because some packages may contain undeclared fish and egg allergens.
Product
LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN.
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1681-2013·2013-07-17
ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect
ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.
Product
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 29 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-707-2013·2013-07-17
FDA Recalls Compounded Dexamethasone Eye Ointment Over Sterility Concerns
Olympia Pharmacy is recalling one unit of compounded BNP/dexamethasone eye ointment because FDA inspection findings raised concerns about sterility assurance and quality control. The listed distribution is nationwide and Puerto Rico.
Product
BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1670-2013·2013-07-17
Abbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk
Abbott Medical Optics is recalling 534 Sovereign Compact Phacoemulsification Systems because they may lose vacuum tone mode during cataract surgery.
Product
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1630-2013·2013-07-17
Eco-Cuisine Basic Pancake Mix Recalled for Salmonella Contamination
Eco-Cuisine is recalling Basic Pancake Mix due to potential Salmonella contamination reported by a raw materials supplier.
Product
Eco-Cuisine Basic Pancake Mix, SKU: TV25PANC, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.
Category
Food
Distribution
0 states
HighFDA (Food)·F-1621-2013·2013-07-17
Eco-Cuisine Chocolate Brownie Mix Recalled for Salmonella Contamination Risk
Eco-Cuisine is recalling Chocolate Brownie Mix due to potential salmonella contamination reported by a raw materials supplier.
Product
Eco-Cuisine Chocolate Brownie Mix, SKU: AA01BRWN, Pack size 1 lb bag, 10 bags per case, and SKU: AA25BRWN 25 lbs bulk bag, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Category
Food
Distribution
0 states
HighFDA (Food)·F-1627-2013·2013-07-17
Eco-Cuisine Scone Mix Recalled for Potential Salmonella Contamination
Eco-Cuisine is recalling Basic English Scone Mix due to potential salmonella contamination reported by a raw materials supplier.
Product
Eco-Cuisine Basic English Scone Mix, SKU: CM25SCONE, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1723-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-1585-2013·2013-07-17
ABCO Laboratories Recalls Soy Protein Isolate Due to Supplier Recall
ABCO Laboratories is recalling soy protein isolate products as part of a larger recall initiated by its supplier of soy-based products.
Product
Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was…
Category
Food
Distribution
2 states
HighCPSC·13240·2013-07-17
Thermobaby Bath Seats Recalled by SCS Direct Due to Drowning Hazard
SCS Direct is recalling Thermobaby Aquababy Bath Ring Seats sold at Amazon.com because they can tip over, posing a drowning risk to babies.
Product
Thermobaby Aquababy Bath Ring Seats
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-1640-2013·2013-07-17
Chs Inc Recalls Solcon S Soy Protein Concentrates Due to Salmonella Risk
Chs Inc is recalling Solcon S Functional Soy Protein Concentrates produced in Israel due to potential Salmonella contamination. The product was distributed internationally and did not enter the U.S. market.
Product
Solcon S Functional Soy Protein Concentrates. Item No. / Item Description: 3232212 / Solcon S 110 GMO, and 32211 / Solcon S110 GMO
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Implants
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee implants due to a design flaw that may cause bone impingement.
Product
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-1590-2013·2013-07-17
Mother Earth Veggie Burger Recalled for Potential Salmonella Contamination
Mother Earth International LLC is recalling Veggie Burger Textured Vegetable Protein products due to potential Salmonella contamination from a soy protein isolate ingredient.
Product
Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2013·2013-07-17
Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection
Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap connection after storage.
Product
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1652-2013·2013-07-17
Christian Cheese Horseradish Cheddar Cheese Recalled for Undeclared Soy
Christian Cheese, LLC is recalling Horseradish Cheddar Cheese due to undeclared soy lecithin and soybean oil. The product was distributed in Colorado and Oklahoma.
Product
Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, and Horseradish. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32…
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1712-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 46 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1694-2013·2013-07-17
Siemens Mammomat Inspiration Mammography Systems Recalled for Potential Malfunction
Siemens is recalling three Mammomat Inspiration mammography systems due to a potential malfunction that could cause patient bruising during specific imaging procedures.
Product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1674-2013·2013-07-17
Fresenius Liberty Cycler Set Recalled for Potential Leakage During Dialysis
Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.
Product
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1717-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-1626-2013·2013-07-17
Eco-Cuisine English Scone Mix Recalled for Salmonella Contamination Risk
Eco-Cuisine is recalling English Scone Mix due to potential salmonella contamination reported by a raw materials supplier.
Product
Eco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Category
Food
Distribution
0 states