Browse recalls
Alert level: Class I
- 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter - 2024-03-13 · US FDA — Medical DevicesClass I
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ - 2024-03-06 · US FDA — Medical DevicesClass I
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 - 2024-03-05 · US FDA — Medical DevicesClass I
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology - 2024-02-26 · US FDA — Medical DevicesClass I
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF - 2024-02-20 · US FDA — Medical DevicesClass I
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 - 2024-02-07 · US FDA — Medical DevicesClass I
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS - 2024-02-07 · US FDA — Medical DevicesClass I
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F - 2024-01-10 · US FDA — Medical DevicesClass I
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 - 2023-12-29 · US FDA — Medical DevicesClass I
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000 - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 - 2023-12-19 · US FDA — Medical DevicesClass I
smiths medical Medfusion Model 3500 Syringe pump - 2023-12-19 · US FDA — Medical DevicesClass I
smiths medical Medfusion Model 4000 syringe pump - 2023-12-15 · US FDA — Medical DevicesClass I
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4 - 2023-12-15 · US FDA — Medical DevicesClass I
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074 - 2023-12-15 · US FDA — Medical DevicesClass I
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292 - 2023-12-13 · US FDA — Medical DevicesClass I
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit - 2023-12-08 · US FDA — Medical DevicesClass I
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M - 2023-11-30 · US FDA — Medical DevicesClass I
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap - 2023-11-30 · US FDA — Medical DevicesClass I
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE - 2023-11-29 · US FDA — Medical DevicesClass I
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 - 2023-11-20 · US FDA — Medical DevicesClass I
AirTouch F20 Full Face Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirTouch N20 Nasal Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirFit F30 Full Face Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirFit N10 Nasal Masks and User Guide - 2023-11-17 · US FDA — Medical DevicesClass I
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF D - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, R - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NUR - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 - 2023-11-01 · US FDA — Medical DevicesClass I
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3 - 2023-10-16 · US FDA — Medical DevicesClass I
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster - 2023-10-11 · US FDA — Medical DevicesClass I
VariSoft infusion set, Model Number 1002828 - 2023-09-22 · US FDA — Medical DevicesClass I
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. - 2023-09-21 · US FDA — Medical DevicesClass I
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System - 2023-09-21 · US FDA — Medical DevicesClass I
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System - 2023-09-15 · US FDA — Medical DevicesClass I
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur - 2023-09-13 · US FDA — Medical DevicesClass I
Astral 100 and Astral 150 ventilators - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099 - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099 - 2023-07-31 · US FDA — Medical DevicesClass I
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 - 2023-07-06 · US FDA — FoodClass I
Betty Lou's Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, shelf-stable, 12-month shelf life, 1. - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H - 2023-06-15 · US FDA — Medical DevicesClass I
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 - 2023-06-14 · US FDA — Medical DevicesClass I
Impella LD intravascular micro axial blood pump, Product Number 005082 - 2023-06-14 · US FDA — Medical DevicesClass I
Impella 5.0 intravascular micro axial blood pump, Product Number 005062 - 2023-06-14 · US FDA — Medical DevicesClass I
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 - 2023-06-06 · US FDA — Medical DevicesClass I
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828 - 2023-06-05 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0 - 2023-06-05 · US FDA — Medical DevicesClass I
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85