Recalls affecting Hawaii
Notices that name Hawaii in their distribution area, plus every nationwide recall — nationwide recalls reach Hawaii too.
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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, 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).
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Class II · 4 months ago
Medtronic Perfusion Systems Octopus 4 Tissue Stabilizer, Model 29400 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…
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Class II · 4 months ago
Intuitive Surgical, Inc. Da Vinci ASSY, PSS, SP1098 recall: Operative components of surgical systems potentially distributed with E-brake
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake…
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Class II · 4 months ago
Stryker Neurovascular Inzone Detachment System, REF: M00345100950 recall: Embolization coil detachment system devices may experience premature battery
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint…
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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 I · 4 months ago
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP 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
Zimmer, Inc. Off-Axis Alliance Glenoid, Right, 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
Medtronic Perfusion Systems Octopus Evolution AS Tissue Stabilizer, Model TS2500 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…
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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, 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
Philips Avalon Fetal Monitor, FM20 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
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
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 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
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
Ventec Life Systems, Inc. VOCSN+Pro package, REF: PRT-00853-000 recall: Respiratory system intended to provide continuous/intermittent ventilator
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm…
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Medium, Augment 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
Surgify Halo, 4.0 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, 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
CareFusion 213, LLC BD ChloraPrep FREPP Clear, and 70% v/v isopropyl alcohol ) 1.5 mL recall: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may…
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Class II · 4 months ago
Amgen, Inc. Sensipar Tablets, 30mg, 30-count bottles recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
Amgen, Inc. Sensipar Tablets, 90mg, 30-count bottles recall: CGMP Deviations
CGMP Deviations