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All recalls7,798 total

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Boichik Bagels, Inc. — boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate,

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

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University of California Health Milk Bank — 001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC

Product is potentially contaminated with foreign material (plastic particles).

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Boichik Bagels, Inc. — boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

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Zep Inc — Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, N

Microbial contamination of sterile products

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SUN PHARMACEUTICAL INDUSTRIES INC — Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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SUN PHARMACEUTICAL INDUSTRIES INC — Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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Total Nutrition Inc — 1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules)

Product may be contaminated with Salmonella.

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Abiomed, Inc. — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Potential for thrombus formation during prolonged use of the introducer.

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Abiomed, Inc. — Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Potential for thrombus formation during prolonged use of the introducer.

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Abiomed, Inc. — Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Potential for thrombus formation during prolonged use of the introducer.

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Abiomed, Inc. — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Potential for thrombus formation during prolonged use of the introducer.

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Medtronic Heart Valves Division — Medtronic Harmony Delivery Catheter System

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

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Hamilton Medical AG — IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

A
Alb-USA Enterprises Inc — El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per

Undeclared colors (FD&C Yellow 5 and FD&C Red 40).

F
Fairhope Roasting Company — Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only

Product requires refrigeration but the label is missing a "Keep Refrigerated" statement

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Keystone Industries — DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Fran

Defective container:may contain bottles with incomplete seals

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Keystone Industries — PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-0

Defective container:may contain bottles with incomplete seals

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Keystone Industries — Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le

Defective container:may contain bottles with incomplete seals

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Keystone Industries — Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

Defective container:may contain bottles with incomplete seals

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Keystone Industries — Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

Defective container:may contain bottles with incomplete seals

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Keystone Industries — safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in US

Defective container:may contain bottles with incomplete seals

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Keystone Industries — Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-000

Defective container:may contain bottles with incomplete seals

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Bard Access Systems, Inc. — CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Boston Scientific Corporation — CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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Medline Industries, LP — Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Numbe

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Bard Access Systems, Inc. — 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Medline Industries, LP — Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Medline Industries, LP — Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Bard Access Systems, Inc. — CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Medline Industries, LP — Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Medline Industries, LP — Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Bard Access Systems, Inc. — CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S41

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Bard Access Systems, Inc. — 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Bard Access Systems, Inc. — CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Baxter Healthcare Corporation — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing de

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

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Medline Industries, LP — Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number:

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Medline Industries, LP — Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Num

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

B
Boston Scientific Corporation — CRE Pro Wireguided 10-12mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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Elekta, Inc. — MOSAIQ Oncology Information System

Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

B
Bard Access Systems, Inc. — 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV cat

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

B
Boston Scientific Corporation — CRE Pro Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

B
Boston Scientific Corporation — CRE Pro Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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Medline Industries, LP — Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

B
Boston Scientific Corporation — CRE Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

B
Bard Access Systems, Inc. — CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Medline Industries, LP — Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

B
Boston Scientific Corporation — CRE Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

B
Boston Scientific Corporation — CRE Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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Medline Industries, LP — Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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Windstone Medical Packaging, Inc. — A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

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