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High RiskFDA
B Braun Medical Inc
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, ...
Medical Devices·12,225,913 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar...
Medical Devices·5,448 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volu...
Medical Devices·10,536 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volu...
Medical Devices·32,436 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pu...
Medical Devices·46,250 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·31,392 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume P...
Medical Devices·11,650 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum...
Medical Devices·0 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·12,200 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·12,168 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·4,536 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·10,896 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·259,392 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·1,861,111 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·5,952 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume P...
Medical Devices·32,500 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·98,568 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volu...
Medical Devices·58,752 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·11,832 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·187,464 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·45,288 affected·Oct 29, 2025
High RiskFDA
Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Medical Implants·6,591 affected·Oct 29, 2025
High RiskFDA
Copan Italia
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (W...
Medical Devices·122,850 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, O...
Medical Devices·100 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·1,080 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·36,936 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·5,100 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·63,192 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·29,900 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·2,544 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·23,160 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·122,232 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·66,792 affected·Oct 29, 2025
High RiskFDA
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large ...
Medical Devices·3,120 affected·Oct 29, 2025
High RiskFDA
India's Fine Foods, Inc.
3 B Cookware 6
Food·9 affected·Oct 28, 2025
High RiskFDA
India's Fine Foods, Inc.
3 B Cookware 5
Food·10 affected·Oct 28, 2025
High RiskFDA
India's Fine Foods, Inc.
3 B Cookware 4
Food·8 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Agebox
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Agebox
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 ...
Oral Drugs·665 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pr...
Medical Devices·118 affected·Oct 28, 2025
High RiskFDA
Otsuka Icu Medical Llc
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Injectable Drugs·509,360 affected·Oct 27, 2025