Home Healthcare

Sentida Bed SafeControl Handsets Recalled for Unintended Movement

• Sold in North Carolina
• Sold at Wissner-Bosserhoff GMBH

AcoSound Hearing Aids Recalled for Mislabeling and Missing Information

• Sold in New York
• Sold at Blaid

Breas Medical, Inc.: Mouthpieces and Ventilation Kits Recalled for Insufficient Ventilation Risk

• Distributed nationwide
• Sold at Breas Medical, Inc.

Liberty Medical Solutions, LLC: Multi-Mode Stimulators Recalled for Missing Safety Warnings

• Sold in 5 states
• Sold at Authorized medical device distributors, Direct distribution

Monarch Rollators Recalled Due to Fall Hazard from Backrest Disengagement

• Distributed nationwide
• Sold at Nova Ortho-Med Inc, Medical supply distributors

Insulet Corporation: Omnipod 5 Automated Insulin Delivery System Recalled for App Connectivity Errors

• Distributed nationwide
• Sold at Insulet Corporation
• 2,168 complaints received; 9 MDRs submitted; no serious injuries reported.

Philips Trilogy, Aeris, and LifeVent Ventilators Recalled for Flow Inaccuracy

• Distributed nationwide
• Sold at Authorized Medical Distributors, Hospitals +1 more
• 154,564 units affected

B. Braun Medical, Inc.: Infusomat Administration Sets Recalled for Tubing Defects and Infusion Errors

• Distributed nationwide
• Sold at B. Braun Medical distributors, hospitals +1 more
• 33,820,976 units affected

Baxter Healthcare Corporation: Clearlink Solution Sets Recalled for Potential Drip Chamber Leaks

• Distributed nationwide
• Sold at Hospital and clinical supply chains
• 26,592 units affected

Tandem t:slim X2 and Mobi Insulin Pumps Recalled for Software Defect

• Distributed nationwide
• Sold at Medical equipment suppliers, Specialty pharmacies +1 more
• 122,958 units affected

iBOT Personal Mobility Device Recalled for Tipping Hazard

• Sold in 13 states
• Sold at Mobius Mobility LLC, Authorized Mobility Distributors

Philips Respironics, Inc.: This device does not indicate for use in patients with respiratory failure.

Medline Homecare Beds Recalled for Fire and Overheating Risk

• Distributed nationwide
• Sold at Medical equipment distributors, Homecare providers
• 58 complaints of pendant sparking, burning, melting, smoking or fire.

GCE Healthcare Zen-O lite Oxygen Concentrators Recalled for Incorrect Alarms

• Sold in 9 states
• Sold at Authorized Medical Distributors, Durable Medical Equipment Providers

Invacare Corporation: Homecare & G-Series Bed Components Recalled for Potential Weld Defects

• Distributed nationwide
• Sold at Authorized medical equipment dealers, Specialty retailers

Breas Medical, Inc.: Vivo 45 LS Ventilators Recalled for Potential Formaldehyde Exposure

• Distributed nationwide
• Sold at authorized medical distributors
• Formaldehyde contamination

Securitas Healthcare LLC: Arial Patient Alarms Recalled for Premature Battery Depletion

• Distributed nationwide
• Sold at Securitas Healthcare LLC, Healthcare facilities

Myosa for Kids Mouthguards Recalled for Lack of FDA Premarket Clearance

• Sold in 26 states
• Sold at Specialty retailers, Medical/Dental distributors

Safeguard US Operating LLC: HAWK Warming Grids and Hypothermia Sets Recalled for Incorrect Expiration Dates

• Sold in 16 states
• Sold at Safeguard US Operating LLC

Cardinal Health 200, LLC: Monoject Syringes Recalled Due to Pump Compatibility and Brand Removal Issues

• Distributed nationwide
• Sold at medical supply distributors
• 701,678 units affected

MEDLINE INDUSTRIES, LP - Northfield: HUDSON RCI Addipak Vials Recalled for Potential Sterility Failure

• Distributed nationwide
• Sold at Authorized distributors, Medical supply retailers
• 18,000 units affected

Baxter MiniCap PD Transfer Sets Recalled for Potential Chemical Exposure

• Distributed nationwide
• Sold at Authorized Medical Distributors, Hospitals +1 more
• Non-dioxin-like polychlorinated biphenyl acids (PCBAs), Non-dioxin-like polychlorinated biphenyls (PCBs) contamination

Baxter Healthcare Corporation: Centrella Bed Mattresses Recalled for Mattress Cover Delamination

• Distributed nationwide
• Sold at Government distribution, Military distribution +1 more
• 38,136 units affected

Avanos Medical, Inc.: MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Missing Risk Information

• Distributed nationwide
• Sold at Government and military distribution, Medical supply distributors
• 53,384 units affected