Latest recalls — page 74
Older notices, newest first.
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Long, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Surgify Halo, 40 mm, Long, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis recall: Five complaints have been received identifying issues where the plastic
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
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Class II · 4 months ago
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x recall: Due to manufacturing error, hexalobe screws used with wrist fixation system
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/ recall: Five complaints have been received identifying issues where the plastic
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class I · 4 months ago
Abiomed Impella CP Set with SmartAssist containing affected 14Fr Low recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 4.0 mm, Short, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Short, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
-
Class II · 4 months ago
Surgify Halo, 3.0 mm, Extendable, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Long, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
-
Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
-
Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Medium, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class I · 4 months ago
Medline Convenience Kits: 1) Open Heart CDS recall: The Medline Convenience Kits contain Arrow Kits and Sets that include
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in…
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Class II · 4 months ago
TMJ Bilateral Implants, REF: CHG020 recall: Custom temporomandibular joint implant may have contained incorrect
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a…
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Class I · 4 months ago
Medline Convenience Kits: 1) Drawer 6 Central Line Insertio recall: The Medline Convenience Kits contain Arrow Kits and Sets that include
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in…
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Extendable, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Surgify Halo, 3.0 mm, Short, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recall: Monitor has incorrect assembly of the speaker connector which can cause
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of…
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Class II · 4 months ago
Medtronic Perfusion Systems Octopus Evolution Tissue Stabilizer, Model TS2000 recall: During the manufacturing process, Medtronic personnel identified an assembly
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was…