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All recalls8,501 total

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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.

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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.

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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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/15; System Code: 722058;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/20; System Code: 722038;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD10C; System Code: 722001;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Q

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Wilson-Cook Medical Inc. — Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

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Angiodynamics, Inc. — AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Q

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pou

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H78710714024

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouc

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/15 OR Table; System Code: 722059;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

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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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

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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