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All recalls8,504 total

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E.A. Sween Co. — Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344.

Potential foreign material (plastic)

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Good Way Trading Group Inc — BaiLiFeng Dried Cinnamon Powder; Net Wt 4 oz/114G; Good Way Trading Group Inc 58-51 Maspeth Avenue Maspeth NY 11378; Product of China; Ingredients: Dried Cinnamon; UPC cod

contains high levels of lead (10.7 mg/kg)

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Twin Sisters Creamery, LLC — Twin Sisters Creamery Peppercorn cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, whole peppercorn

Raw milk Peppercorn cheese is recalled due to E.coli O26:H11

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Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for :

Failed stability specifications: Out of specification for hardness test

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Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY

Failed stability specifications: Out of specification for hardness test

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform lo

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Siemens Medical Solutions USA, Inc — MAMMOMAT Inspiration;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Siemens Medical Solutions USA, Inc — MAMMOMAT Fusion;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time con

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monit

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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GE Medical Systems, LLC — Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care prof

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

S
Siemens Medical Solutions USA, Inc — MAMMOMAT Revelation;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care pro

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

E
Edan Diagnostics — Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then a

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform l

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and e

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring o

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

E
Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient wit

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

E
Echo Lake Foods, Inc. — EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville

Potential Listeria monocytogenes contamination.

I
Ice Cream Factory, LLC — Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream Way, Lebanon, MO 65536"

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

I
Ice Cream Factory, LLC — Strawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with graham cracker swirl, 2.5-gal Tub, Ne

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

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Zydus Pharmaceuticals (USA) Inc — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmac

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

D
Datascope Corp. — Cardiosave Rescue

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

D
Datascope Corp. — Cardiosave Hybrid

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

B
Becton Dickinson & Co. — BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

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Zydus Pharmaceuticals (USA) Inc — clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (ND

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

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Zydus Pharmaceuticals (USA) Inc — clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (ND

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Z
Zydus Pharmaceuticals (USA) Inc — clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 167

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

O
Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

B
BioFire Diagnostics, LLC — BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

O
Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Firm is initiating a removal due to continued reports of adverse events.

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Olympus Corporation of the Americas — Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

O
Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

O
Olympus Corporation of the Americas — Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

O
Olympus Corporation of the Americas — Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

K
Kenvue Brands LLC — TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC

Defective Container

B
Bristol-Myers Squibb Company — Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543

Lack of Assurance of Sterility.

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