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All recalls8,424 total

C
Cook Incorporated — COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UN

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

T
Tornier, Inc — Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

C
Cook Incorporated — COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-N

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Ord

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUST

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

C
Cook Incorporated — COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

D
Daavlin Distributing Company — Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

D
Daavlin Distributing Company — Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

D
Daavlin Distributing Company — Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

D
Disaronno Ingredients S.p.a. — Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed 8 bags per master case of 2 Kg (4.41 lb) each total case weight,16 Kg / 35.27 lb

Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *

K
Koven Technology, Inc. — Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Softw

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

A
Ajinomoto Foods North America Inc. — Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Product packaging is flexible bags in a master case or flexible bags

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Pepper

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a mast

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 0700778

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. Retail bag UPC 00521482. Product packaging is flexible bags in a master case or flexible bags

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Produc

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product pa

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 0763

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There ar

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

F
FRITO-LAY NORTH AMERICA, INC. — Miss Vickies Spicy Dill Pickle; 8 oz bag

Undeclared Allergen: Milk

A
Ajinomoto Foods North America Inc. — Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in an umami dashi sauce Net

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

A
Ajinomoto Foods North America Inc. — Item 6430153 Ajinomoto Vegetable Gyoza Dumplings. Net wt. 24.7oz. per bag. Retail box UPC: 071757010109. Product packaging is flexible bags in a master case or fl

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

K
K.C. Pharmaceuticals, Inc — Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree

Lack of Assurance of Sterility

R
Rising Pharma Holding, Inc. — Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin:

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

K
K.C. Pharmaceuticals, Inc — Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 430

Lack of Assurance of Sterility

K
K.C. Pharmaceuticals, Inc — Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

Lack of Assurance of Sterility

K
K.C. Pharmaceuticals, Inc — Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceutica

Lack of Assurance of Sterility

K
K.C. Pharmaceuticals, Inc — EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY:

Lack of Assurance of Sterility

K
K.C. Pharmaceuticals, Inc — Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, O

Lack of Assurance of Sterility

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K.C. Pharmaceuticals, Inc — Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KA

Lack of Assurance of Sterility

K
K.C. Pharmaceuticals, Inc — STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by

Lack of Assurance of Sterility

O
Owen Biosciences Inc. — FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse F

Chemical contamination: Presence of benzene

O
Owen Biosciences Inc. — SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.

Chemical contamination: Presence of benzene

O
Owen Biosciences Inc. — SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, C

Chemical contamination: Presence of benzene

O
Owen Biosciences Inc. — HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027

Chemical contamination: Presence of benzene

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/20 OR Table; System Code: 722039;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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