Recalls and safety alerts from the FDA, newest first.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 233 units
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite. — TMJ Solutions Inc · Class II · Ongoing · 1
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 6775 units
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
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 burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 15 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
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