The latest headlines across every section, pulled from official and open-access sources.
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. — Windstone Medical Packaging, Inc. · Class I · Ongoing · 200 units
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. — Zimmer Surgical Inc · Class II · Ongoing · 45160
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus. — Medacta Usa Inc · Class II · Ongoing · 50
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. — BD SWITZERLAND SARL · Class II · Ongoing · 50 devices
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user. — Hamilton Medical AG · Class II · Ongoing · 962 units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due t… — Insulet Corporation · Class I · Ongoing · 289,046 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 8,795
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. — Siemens Medical Solutions USA, Inc · Class II · Ongoing · 119 units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after ad… — Baxter Healthcare Corporation · Class I · Ongoing · 10540 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 967 kits
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 432 kits
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after ad… — Baxter Healthcare Corporation · Class I · Ongoing · 0
Potential contamination with plastic material — MARS SNACKING · Class II · Ongoing · 21,114 cases
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required) — Fry Pie Factory LLC · Class II · Completed · 850 individual units
Product may be contaminated with Salmonella Typhimurium — MOGO Moringa LLC · Class I · Ongoing · 23,186 bottles
Undeclared peanuts. — Western Mixers Produce & Nuts, Inc. · Class I · Ongoing · 29 cases (6 - 9oz packages/case) = 174 packages
Dietary supplement product Vista MAX contains undeclared Yellow#5. — Provision Health Corp. dba PH Labs · Class II · Ongoing · 6,967 units across all lots
Dietary supplement product Ocular Plus contains undeclared Yellow#5. — Provision Health Corp. dba PH Labs · Class II · Ongoing · 6,967 units across all lots
Elevated coliforms — Wells Enterprises, Inc. · Not Yet Classified · Ongoing · 195 cases
Product may be contaminated with Clostridium botulinum. — NARA ORGANICS INC · Class I · Ongoing · 377,610 cans
Potential contamination with plastic material — MARS SNACKING · Class II · Ongoing · 17,218 cases
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 5,801 bottles
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 1,500 bottles