Recalls and safety alerts from the FDA, newest first.
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. — DT MedTech, LLC · Class II · Ongoing
Inadvertent distribution of sealed pouches that had not undergone validated sterilization. — AVID Medical, Inc. · Class II · Ongoing
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. — ICU Medical, Inc. · Class II · Ongoing
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to… — Inter-Med Llc · Class II · Ongoing
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. — ICU Medical, Inc. · Class II · Ongoing
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. — D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Class II · Ongoing
The cannulation of the CCS screw is not centered. — Medartis AG · Class II · Ongoing
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. — GE Medical Systems, LLC · Class II · Ongoing
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. — Abbott Medical · Class II · Ongoing
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. — BERLIN HEART GMBH · Class II · Ongoing
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 809 (16-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 7,856 (15-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 1,334 (15-oz) units
Product may be contaminated with Salmonella. — Total Nutrition Inc · Class I · Ongoing · 13,000 bottles
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 149 (26-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 221 (30-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 442 (16-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 190 (48-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 257 (47-oz) units
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). — Galaxy RG Corp · Class II · Ongoing · 375 (26-oz) units
Undeclared FD&C Red 40 — Refresqueria Estrella Inc. · Class III · Ongoing · Total: 2,111---14 oz-1,291, 64 oz-114 and 120 oz -706