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Showing 3301–3320 of 11714 results

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Cucumber Select (Hardies Fresh Foods) – Salmonella Risk (2024)

Cucumbers have the potential to be contaminated with Salmonella

FDANov 27, 2024TX• HARDIES FRESH FOODS

Cinacalcet Tablets 60mg (AvKARE) – Nitrosamine Impurity (2024)

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

O & M HALYARD, INC.: Brand Name: HALYARD Product Name: Laparotomy Pack Model/C...

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Moderate

FDANov 26, 2024Nationwide• O & M HALYARD, INC.

3M Unitek Corporation: 3M Unitek Transbond Plus Self-Etching Primer REF 712-090...

Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

FDANov 26, 2024Nationwide• 3M Unitek Corporation

Beckman Coulter, Inc.: Access Intact PTH assay, a paramagnetic particle, chemilu...

Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

FDANov 26, 2024Nationwide• Beckman Coulter, Inc.

Applied Medical Technology Inc: AMT Mini Enteral Extension Set, 12" Right Angle Feeding S...

The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.

FDANov 26, 2024CA, CT, FL +15 more• Applied Medical Technology Inc

Olanzapine Tablets 2.5mg (Macleods) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 25, 2024Nationwide• Macleods Pharmaceuticals Ltd

Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom: Eclipse PRO REF 98700 The Spacelabs model 98700 is a por...

Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

FDANov 25, 2024AR, CA, CO +19 more• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

GE Medical Systems, LLC: GE Healthcare Optima XR220amx, Mobile Digital Radiographi...

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom: Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a...

Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

FDANov 25, 2024AR, CA, CO +19 more• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Angiodynamics, Inc.: AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Pr...

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.

FDANov 25, 2024Nationwide• Angiodynamics, Inc.

Spacelabs Healthcare, Inc.: Xhibit Telemetry Receiver, Model 96280, with Service Manu...

Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

FDANov 25, 2024AL, AK, AZ +41 more• Spacelabs Healthcare, Inc.

Spacelabs Healthcare, Inc.: Xhibit Telemetry Receiver with Software, Model 96280. Int...

Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

FDANov 25, 2024AL, AR, CO +24 more• Spacelabs Healthcare, Inc.

GE Medical Systems, LLC: GE Healthcare Optima XR200amx, Mobile Digital Radiographi...

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Optima XR240amx, Mobile Digital Radiographi...

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

Spectranetics Corporation: Turbo Elite Laser Atherectomy Catheter Model Number / UDI...

Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

FDANov 25, 2024AL, AK, AZ +44 more• Spectranetics Corporation

Olympus Corporation of the Americas: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type ...

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

FDANov 25, 2024Nationwide• Olympus Corporation of the Americas

Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand: Otological Ventilation Tube - T-Tube 6mm - Silicone; Prod...

Lack of 510(k) clearance.

FDANov 24, 2024Nationwide• Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand

VCF Contraceptive Gel (Apothecus) – Assay Deviation (2024)

CGMP deviations: out of specifications for assay

Class IIModerate

FDANov 22, 2024Nationwide• Apothecus Pharmaceutical Corp.

Dihydroergotamine Mesylate Injection (Provepharm Inc.) – Discoloration (2024)

Discoloration

Class IIModerate

FDANov 22, 2024Nationwide• Provepharm Inc.

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