Recalls and safety alerts from the FDA, newest first.
Foreign object (stainless steel dust/flakes or shreds of plastic) — Dakota Honey Company · Class II · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. — Edwards Lifesciences, LLC · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flick… — Dexcom, Inc. · Class II · Ongoing
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. — GE Medical Systems, LLC · Class II · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Due to broken connector which may result in a temporary interruption of prescribed cold therapy. — DJO, LLC · Class II · Ongoing
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. — Hologic, Inc · Class II · Ongoing
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. — GE Medical Systems, LLC · Class II · Ongoing
Out-of-specification endotoxin result that did not meet the acceptance criteria. — Integra LifeSciences Corp. (NeuroSciences) · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Contains undeclared Blue 1 — Raja Foods and Vegetables Inc. · Class II · Ongoing
Product has the potential to be contaminated with Salmonella. — Pure Ground Ingredients, Inc. · Class I · Completed
Undeclared allergens (wheat and soy). — Ferris Coffee and Nut Company, Inc. · Class II · Ongoing
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella. — Sugar Foods LLC · Class I · Ongoing