Browse recalls
Alert level: Class I
- 2025-07-21 · US FDA — Medical DevicesClass I
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen - 2025-07-14 · US FDA — Medical DevicesClass I
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS - 2025-07-10 · US FDA — Medical DevicesClass I
IDM-MICRO-R. Electrical wheelchair component. - 2025-07-10 · US FDA — Medical DevicesClass I
Micro Joystick R-net. Electrical wheelchair component. - 2025-07-09 · US FDA — Medical DevicesClass I
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. - 2025-06-26 · US FDA — Medical DevicesClass I
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H - 2025-06-03 · US FDA — Medical DevicesClass I
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic - 2025-05-21 · US FDA — Medical DevicesClass I
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, - 2025-05-15 · US FDA — Medical DevicesClass I
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36 - 2025-05-12 · US FDA — Medical DevicesClass I
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK- - 2025-05-12 · US FDA — Medical DevicesClass I
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 - 2025-03-13 · US FDA — Medical DevicesClass I
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear - 2025-02-27 · US FDA — Medical DevicesClass I
t:slim X2 Insulin Pump with Interoperable Technology - 2025-02-26 · US FDA — Medical DevicesClass I
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R - 2025-02-05 · US FDA — Medical DevicesClass I
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: - 2025-01-30 · US FDA — Medical DevicesClass I
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3 - 2025-01-30 · US FDA — Medical DevicesClass I
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3 - 2025-01-15 · US FDA — Medical DevicesClass I
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl - 2025-01-10 · US FDA — Medical DevicesClass I
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro - 2025-01-10 · US FDA — Medical DevicesClass I
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F, - 2024-12-26 · US FDA — Medical DevicesClass I
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to - 2024-12-12 · US FDA — Medical DevicesClass I
Impella RP Flex with SmartAssist; Product Number: 1000323; - 2024-12-11 · US FDA — Medical DevicesClass I
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th - 2024-12-10 · US FDA — Medical DevicesClass I
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105 - 2024-11-20 · US FDA — Medical DevicesClass I
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati - 2024-11-20 · US FDA — Medical DevicesClass I
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis - 2024-09-25 · US FDA — Medical DevicesClass I
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 - 2024-09-25 · US FDA — Medical DevicesClass I
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne - 2024-09-16 · US FDA — Medical DevicesClass I
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi - 2024-09-03 · US FDA — Medical DevicesClass I
GE Heathcare Giraffe OmniBed; neo natal incubator - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-07-31 · US FDA — Medical DevicesClass I
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1 - 2024-07-24 · US FDA — Medical DevicesClass I
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System - 2024-07-19 · US FDA — Medical DevicesClass I
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb - 2024-07-16 · US FDA — Medical DevicesClass I
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S - 2024-07-03 · US FDA — FoodClass I
The recalled product is mis-labeled as Ancient Grain + Vegetable Salad item #25247. Product is perishable, refrigerate - 2024-05-29 · US FDA — Medical DevicesClass I
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes - 2024-05-24 · US FDA — FoodClass I
Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans - 2024-04-30 · US FDA — Medical DevicesClass I
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U - 2024-04-18 · US FDA — FoodClass I
Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak - 2024-04-18 · US FDA — FoodClass I
Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch - 2024-04-18 · US FDA — Medical DevicesClass I
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP V30 Auto Ventilator, Part Number 1111178 - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111 - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11 - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter