FDA regulations

BD Kiestra ReadA lab automation system (Catalog No. 446948) issued Class II recall affecting 82 units for potential connectivity issues causing delays in plate retrieval after system reboot, with no impact on test results or sample integrity.

Imu-Tek Animal Health recalls 1,003 bottles of Colostrum-5 capsules distributed across 29 states due to potential under-processing that may cause temporary or reversible health problems.

Baxter Healthcare issues Class I recall of Blue Ventilator Adapter Module (Product Code M07937) for Volara Respiratory Therapy system due to risk of undetected oxygen desaturation or barotrauma in home care settings.

Medline Industries recalls 9 kits (SKUs DYKM2720, ENFITDISCKIT, and one other) with ENFit G-tube connectors that may not seal properly due to dimensional specification failures, risking leakage and requiring clinical intervention.

Philips Medical Systems recalls 461 units (198 in US) of ALLURA Xper FD20 biplane X-ray systems due to wired foot switch malfunction that may prevent or intermittently disable imaging initiation.

Mentor Texas recalls Artoura Breast Tissue Expanders (Class II) due to potential dull or blunt needle tips that may be difficult to advance or break; affected units distributed worldwide including US, Canada, and multiple international markets.

Civco Medical Instruments recalls 20 units of eTRAX Needle System Starter Kit and related products across Ohio, Pennsylvania, Washington, and China due to needle tip position detection errors that may cause temporary health issues.

Medtronic MiniMed insulin pumps across Paradigm, 600, and BLE 700 series are subject to a Class II recall due to unintended insulin over- and under-delivery caused by gravitational force changes when pump elevation relative to infusion site varies.

Medline Industries recalls Class II thoracic robot kits containing defective Olympus biopsy valves that may shed rubber fragments into patients' airways, potentially requiring surgical removal.

Appco Pharma recalls 88,008 bottles of prazosin hydrochloride capsules nationwide due to excess nitrosamine impurities detected in manufacturing.

Amneal Pharmaceuticals recalls 29,542 nationwide bottles of tramadol hydrochloride 50 mg tablets due to out-of-specification N-nitroso-desmethyl-tramadol impurity found during stability testing.

Oxoid Australia's Microbact 12L identification kit (lot 4494873) is subject to a Class II recall due to potential misidentification of organisms from inconclusive color reactions; 2 kits distributed nationwide in Georgia and California.

Abiomed recalls 62 Automated Impella Controller units internationally due to potential delay in "Purge System Blocked" alarm display with first generation Impella 5.5 pumps, classified as Class I.

Olympus recalls 408 SOLTIVE Premium laser systems worldwide due to a defective 24V power supply module that may render units inoperable or produce smoke and burning smells within the enclosed console.

Siemens Healthcare Diagnostics Class II recall of Atellica CH Enzymatic Hemoglobin A1c test (SMN 11097536) due to potential depressed results when processing with RCRP on the same analyzer.