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Showing 1781–1800 of 3001 results

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Famciclovir Tablets 500mg (Macleods) – Foreign Substance Found (2025)

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

FDAJun 11, 2025Nationwide• Macleods Pharmaceuticals Ltd

GYN Robotic Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

General Laparoscopy Tray (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Low

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Asprire Cristalle Mammography (Fujifilm) – Unapproved Software (2025)

Devices had an unapproved slabbing software function enabled for use.

FDAJun 11, 2025Nationwide• FUJIFILM Healthcare Americas Corporation

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

Major Thoracoscopy Basin (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

GYN Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Partial Nephrectomy Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Endosee Convenience Kit (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

Partial Nephrectomy Robotic (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Laparoscopic Prostatectomy (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Pitavastatin Tablets 2mg (Orient Pharma) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications.

FDAJun 11, 2025NJ• Orient Pharma Co., Ltd. Yunlin Plant

Cardiac Robot Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Pack General Robotic (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

CT Da Vinci Kit (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Laparoscopic GYN (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

General Robotic Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

RADPRO Mobile X-ray (SEDECAL) – Water Resistance Warning (2025)

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

FDAJun 10, 2025CA, IL, NJ• SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain

VITROS Chemistry Products (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

FDAJun 10, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

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