FDA recalls, June 2014: 284 published

127 different companies appear this month.

Risk classification: Class I: 41 · Class II: 226 · Class III: 17

Same month, other agencies:FSIS 9 recallsNHTSA 83 recalls

Recalls this month

DateProduct
June 25, 2014Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS …D-1401-2014John W Hollis Inc
June 25, 2014Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance …Z-1833-2014Synthes, Inc.
June 25, 2014Product label: Amport Foods, Granola, Cinnamon Crunch, 22 oz (1 lb, 6 0z), UPC 0 71725 …F-2034-2014American Importing Co, Inc
June 25, 2014Tam Tams Snack Crackers Garlic Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz…F-2038-2014R.A.B. Food Group LLC
June 25, 2014Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, als…D-1392-2014John W Hollis Inc
June 25, 2014Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manuf…D-1384-2014Thorne Research Inc
June 25, 2014Safety glasses made with "Rage" frames manufactured between February 20, 2014 and Februar…Z-1810-2014Wal Mart Stores, Inc
June 25, 2014Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 m…D-1397-2014John W Hollis Inc
June 25, 2014Market Basket, Dairy-Free, Gluten-Free Pancakes. Each package contains 12 pancakes in a …F-2025-2014Middle East Bakery, Inc.
June 25, 2014Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal…Z-1811-2014Ebi, Llc
June 25, 2014Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea moni…Z-1789-2014Childrens Medical Ventures
June 25, 2014Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, al…D-1406-2014John W Hollis Inc
June 25, 2014Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 CapsuleF-2031-2014Nutrition Center, Inc. dba Nutri-West
June 25, 2014PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Wate…D-1405-2014John W Hollis Inc
June 25, 2014Bulk shelled walnuts packaged in 25 lb. cardboard boxes labeled with GSF LLC, Combo Halve…F-2027-2014Sherman Produce Co
June 25, 2014Synergy XVI Intended for radiation therapy treatment.Z-1724-2014Elekta, Inc.
June 25, 2014Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsule…D-1387-2014Novartis Pharmaceuticals Corp.
June 25, 2014G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosth…Z-1837-2014Biomet, Inc.
June 25, 2014iGUIDE System Product Usage: The intended use of the device is the control of accurat…Z-1807-2014Elekta, Inc.
June 25, 2014Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for …D-1395-2014John W Hollis Inc
June 25, 2014TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only,…D-1385-2014Ferring Pharmaceuticals Inc
June 25, 2014Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07Z-1824-2014Spacelabs Healthcare Inc
June 25, 2014APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234.…Z-1793-2014Gen-Probe Inc
June 25, 2014NIPRO Safe Touch Safety Scalp Vein SetZ-1834-2014Nipro Medical Corporation
June 25, 2014VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- …Z-1804-2014Ortho-Clinical Diagnostics
June 25, 2014Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 CapsuleF-2032-2014Nutrition Center, Inc. dba Nutri-West
June 25, 2014GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. …Z-1808-2014GE Healthcare, LLC
June 25, 2014RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human useZ-1825-2014Ability Dynamics LLC
June 25, 2014Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 …Z-1839-2014ConMed Corporation
June 25, 2014liveGfree Gluten Free Blueberry Pancakes NET WT 14.4 OZ, 12 pancakes Keep Frozen …F-2024-2014American Waffle
June 25, 2014IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The B…Z-1798-2014Boston Scientific Corporation
June 25, 2014LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosp…D-1404-2014John W Hollis Inc
June 25, 2014Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Pr…Z-1826-2014Philips Medical Systems, Inc.
June 25, 2014Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), …F-2035-2014Brunkow Cheese of Wisconsin, Inc.
June 25, 2014G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prost…Z-1838-2014Biomet, Inc.
June 25, 2014Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 m…D-1399-2014John W Hollis Inc
June 25, 2014Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Pu…Z-1809-2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
June 25, 2014Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharm…D-1400-2014John W Hollis Inc
June 25, 2014IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. …Z-1796-2014Boston Scientific Corporation
June 25, 2014IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. Th…Z-1794-2014Boston Scientific Corporation
June 25, 2014Caravelle CHILI POWDER HOT Net Weight 8 oz. (227G), plastic tub, UPC 080736115551. 24 u…F-2029-2014Anhing Corporation
June 25, 2014Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. Th…Z-1788-2014Kerr Corporation
June 25, 2014VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- Fo…Z-1805-2014Ortho-Clinical Diagnostics
June 25, 2014Schnucks walnuts packaged in 10 oz. plastic trays. IPC 003383900325 Packed by Sherman Pr…F-2028-2014Sherman Produce Co
June 25, 2014Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of…F-2041-2014Kodiak Wild Alaska Seafood
June 25, 2014IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. Th…Z-1797-2014Boston Scientific Corporation
June 25, 2014Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 m…D-1403-2014John W Hollis Inc
June 25, 2014MOSAIQ, an oncology information system used to manage workflows for treatment planning an…Z-1800-2014Elekta, Inc.
June 25, 2014Tam Tams Snack Crackers Original Net Wt. 9.6 oz (272 g) Distributed by the Manischewi…F-2040-2014R.A.B. Food Group LLC
June 25, 2014EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a …Z-1803-2014Biomet, Inc.

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