fda regulated Recalls

B Braun Medical Outlook IV Set Recall 162,648 Units for Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Vista IV Set Recall for 74,652 Units Over Backflow and Occlusion Risk

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B. Braun Medical Recalls 12,320 IV Burette Sets Over Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B. Braun Medical SAFELINE IV Sets Recalled for 46,250 Units Over Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical IV Administration Set Recall 11,832 Units Over Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B. Braun Medical Rate Flow IV Set Recalled for 150,664 Units in 2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Illumina NextSeq 550Dx Reagent Kits Recalled for Leaky Flow Cells Affecting 11,916 Units Worldwide

Agebox iKids-Growth Recalled Over Undeclared Ibutamoren

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Twin Sisters Creamery Whatcom Blue Sliced Cheese Recalled for STEC/E. coli Contamination (2025)

Medline Recalls Adhesive Bandages Over Sterility Concerns

Medline Industries recalled 11,291,800 units of Quick Strip Fabric Sterile Adhesive Bandages on October 27, 2025. The recall affects all lots due to potential open seals that compromise sterility. Consumers should stop using these bandages immediately.

Medline Recalls Adhesive Bandages Over Sterility Concerns

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Water Pure My Bladder Recall for E. coli Contamination — 17,612 Bottles (2025)

Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303

EDAN Patient Monitors Recalled Over Cybersecurity Issues

EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.

EDAN Vital Signs Monitor Recalled Over Cybersecurity Issues

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.

Invagen Pharmaceuticals Recalls Lanthanum Carbonate Tablets for Safety Risk

Failed stability specifications: Out of specification for hardness test

GE Medical Systems Recalls Mammography Systems Over Labeling Hazard

GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.

MeriCal Member's Mark Super Greens Recall 698,064 Units Over Salmonella Contamination (2025)

Potential contamination of Salmonella Richmond

3M Scotch TL909-50 Thermal Laminator Recalled for Overheating

Sauna360 Recalls Tylö Halmstad and Kiruna Hybrid Saunas Over Fall Hazard

Bristol-Myers Squibb Opdualag Vial Recall for Sterility Risk: 12,778 Units (2025)

Lack of Assurance of Sterility.