Read & Learn

FDA Recalls

Showing 3,531–3,540 of 40,300 recalls

Last checked for updates 4 days ago: No new recalls

Add Recipe

🍔 Food 💊 Drugs 🏥 Medical Devices

ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube. Class I

Reason: Potential for undetected, deformed a-traumatic tips.

Olympus Corporation of the Americas 20250806 Ongoing

Distributed: Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.

Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC. Class II

Reason: Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.

WASATCH PHOTONICS 20250804 Ongoing

Distributed: U.S.

Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24 Class II

Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

ICU Medical Inc. 20250806 Ongoing

Distributed: Worldwide distribution.

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Class II

Reason: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

CARIS LIFE SCIENCES 20250617 Ongoing

Distributed: U.S. Nationwide distribution in the state of NY.

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 Class II

Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product.

O&M HALYARD INC 20250717 Ongoing

Distributed: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

1
...
352
353
354
355
356
...
4030

Page 354 of 4,030 | Showing 10 recalls

Data provided by openFDA