United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Dried Herring Fish 7 oz.
Improperly eviscerated which may result in Clostridium botulinum contamination
Spring & Mulberry Sea Salt Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), indi...
Potential Salmonella contamination
Joy Masala Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a ...
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Tho...
Presence of Foreign Substance.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Potential presence of Salmonella.
Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Spring & Mulberry Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), indivi...
Potential Salmonella contamination
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (...
Subpotent Drug
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I...
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
6/11oz Sunflower Seeds Salted
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...
Potential for thrombus formation during prolonged use of the introducer.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC01...
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Joy Mint Lassi 16 oz.
Product not adequately pasteurized
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.
Potential presence of Salmonella.