Carefusion 213, Llc

FDA Regulatory Profile

Carefusion 213, Llc appears in FDA public data with 48 recalls — including 15 Class I (most serious) —, 0 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0690-2026, Class II) was initiated on Jul 9, 2026.

Summary

Total Recalls
48 (15 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0690-2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mLJul 9, 2026
D-0647-2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) pJun 11, 2026
D-0645-2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), PacJun 11, 2026
D-0652-2026Class IIBD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5Jun 11, 2026
D-0643-2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IJun 11, 2026
D-0648-2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) pJun 11, 2026
D-0651-2026Class IIBD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mLJun 11, 2026
D-0650-2026Class IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaJun 11, 2026
D-0646-2026Class IIChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x Jun 11, 2026
D-0644-2026Class IIBD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 5Jun 11, 2026
D-0649-2026Class IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaJun 11, 2026
D-0625-2026Class IBD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA))May 28, 2026
D-0624-2026Class IBD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mLMay 28, 2026
D-0622-2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL May 28, 2026
D-0623-2026Class IIBD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)May 28, 2026
D-0518-2026Class IIBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w SteriApr 22, 2026
D-0517-2026Class IIBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w SteriApr 22, 2026
D-0243-2026Class IIBD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA),Dec 17, 2025
D-0441-2025Class IIBD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), PatieMay 15, 2025
D-0259-2025Class IBD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcoFeb 14, 2025