The latest headlines across every section, pulled from official and open-access sources.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 7 units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 11 units
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. — Acumed LLC · Class II · Ongoing · 5,272 units
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 474 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 429 units
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. — Philips North America Llc · Class II · Ongoing · 909 units
Product not adequately pasteurized — Joy Gourmet Foods LLC. · Class II · Ongoing · 50 gallons (total)
Improperly eviscerated which may result in Clostridium botulinum contamination — Prime Food Processing LLC. · Class I · Ongoing · 69 cases
Potential presence of Salmonella. — Utz Quality Foods, LLC · Class I · Ongoing · 300595 Bags
Undeclared allergen, sesame. — Boichik Bagels, Inc. · Class II · Ongoing · 426 packages (6 bagels/package)
Potential presence of Salmonella. — Utz Quality Foods, LLC · Class I · Ongoing · 19200 Bags
Potential presence of Salmonella. — Utz Quality Foods, LLC · Class I · Ongoing · 164640 Bags
potential salmonella contamination — Champion Foods, LLC · Class II · Ongoing · 997,821 retail units
Product not adequately pasteurized — Joy Gourmet Foods LLC. · Class II · Ongoing · 50 gallons (total)
Potential Salmonella contamination — Spring & Mulberry Inc. · Class I · Ongoing · 17,848 individual bars
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew. — George J Howe Company, Inc. · Class I · Ongoing · 578.50 Cases
Potential Salmonella contamination. — Spring & Mulberry Inc. · Class I · Ongoing · 13,922 individual bars