Recalls and safety alerts from the FDA, newest first.
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). — 3B Medical, Inc. · Class II · Ongoing · 375
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 557 units
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. — Oscor Inc. · Class I · Ongoing · 32,934 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 383 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 96 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 8,382 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 680
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 196 units
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 185 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 129 Cases
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product. — Nutricia North America · Class II · Ongoing · 1,363cs/12/12oz pouches + 16,298cs/24/12oz pouches
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 216 Cases
Undeclared peanuts — Fayus Inc. · Class II · Ongoing · 120 cases (16 bags/case)
Foreign material (Glass) was found in the product. — GELLERT GLOBAL GROUP · Class II · Ongoing · 1,150 cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 149 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 167 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 170 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 140 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 121 Cases
Potential E. coli O145:H28 Contamination — Frutas y Hortalizas del Sur S.A. · Class I · Ongoing · 3640 cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 150 Cases
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product. — Nutricia North America · Class II · Ongoing · 2,050cs/12/12oz pouches + 55,310cs/24/12oz pouches
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. — D'Dioses Fruit Pops, Inc. · Class I · Ongoing · 120 cases
Potential for spoilage. — AMY'S KITCHEN INC. · Class II · Ongoing · 15,350 cases (12 cans/case)