Critical
Class I
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
ARROW INTERNATIONAL
FDA Recalls
Page 14 of 39 · 1,907 total recalls
Recalls — Page 14
Critical
Class I
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
ARROW INTERNATIONAL
Critical
Class I
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
ARROW INTERNATIONAL
Critical
Class I
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
ARROW INTERNATIONAL
Warning
Class II
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical
Warning
Class II
Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g)
Undeclared allergens (wheat and soy).
Ferris Coffee and Nut Company
Warning
Critical
Class I
(BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.
Honeyville
Critical
Class I
Automated Impella Controller (AIC); Product Code: 0042-0000-US
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential...
Abiomed
Warning
Class II
NAPROXEN ORAL SUSPENSION
Chemical contamination; presence of lead and lithium above specification
Acella Pharmaceuticals
Critical
Class I
Buttermilk Powder - paper bags 25 kg
Potential contamination with Salmonella.
California Dairies Inc.
Critical
Class I
Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg
Potential contamination with Salmonella.
California Dairies Inc.
Critical
Class I
Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs
Potential contamination with Salmonella.
California Dairies Inc.
Warning
Warning
Class II
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container
Foreign object found inside retail container.
The Mochi Ice Cream Company
Warning
Class II
Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix, 11 oz Net Wt, packed in clear tamper resistant plastic container
Contains undeclared allergens (cashews, milk, and soy).
WE R NUTS
Warning
Class II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA
Lack of Assurance of Sterility
Harrow Eye LLC
Warning
Warning
Class II
Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903
Undeclared Yellow #5
Silver Moon LP dba Loard's Ice Cream
Info
Class III
Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC
Undeclared Red #40, Blue #1, Blue #2
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Chocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Chocolate Showers Ice Cream - 32 oz
Undeclared Soy (with mitigating circumstances)
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Almond Joy Ice Cream - 32 oz
Undeclared Milk, Almonds, Soy, Sulfites.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Banana Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Black Raspberry Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Black Raspberry Marble Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Black Walnut Ice Cream - 32 oz; 56 oz
Undeclared Milk, Walnuts.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Blueberry Cheesecake Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Burgundy Cherry Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1, Blue #2.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Butter Brickle Ice Cream - 32 oz
Undeclared Milk, Almonds, Soy.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Butterscotch Marble Ice Cream - 32 oz
Undeclared Milk.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Caramel Cashew Ice Cream - 32 oz
Undeclared Milk, Cashews, Soy, Sulfites.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Champagne Sherbert - 32 oz
Undeclared Milk, Red #40.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Cherry Vanilla Ice Cream - 32 oz
Undeclared Milk, Red #40.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Chocolate Ice Cream - 32 oz; 56 oz
Undeclared Milk.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Chocolate Marble Ice Cream - 32 oz
Undeclared Milk.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Chocolate Mint Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy, Yellow #5, Blue #1.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Chocolate Showers Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Coconut Pineapple Ice Cream - 32 oz; 56 oz
Undeclared Milk.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Cookies and Cream Ice Cream - 32 oz; 56 oz
Undeclared Milk, Wheat, Soy.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Egg Nog Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Green Tea Ice Cream - 32 oz
Undeclared Milk, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Warning
Warning
Class II
Loard's Lemon Chiffon Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Lime Sherbert - 32 oz
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Loard's Mango Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
Silver Moon LP dba Loard's Ice Cream