Latest recalls — page 76
Older notices, newest first.
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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.
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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 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
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Class II · 4 months ago
Sun Pharmaceutical Industries Inc Perampanel CIII Tablets, 6mg recall: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
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Class III · 4 months ago
ANI Pharmaceuticals, Inc. hydrOXYzine Hydrochloride Oral Solution, USP recall: Presence of foreign substance
Presence of foreign substance
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Class I · 4 months ago
CareFusion 213, LLC BD ChloraPrep Clear and 70% v/v isopropyl alcohol ) recall: Non-Sterility: Due to presence of Aspergillus penicillioides
Non-Sterility: Due to presence of Aspergillus penicillioides.
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Class II · 4 months ago
PReye Vitamin See Antioxidant Preservative Free Eye Drops recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 4 months ago
The Harvard Drug Group LLC Carton Label: Major, Methylergonovine Maleate Tablets recall: Subpotent Drug
Subpotent Drug
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Class II · 4 months ago
Central Admixture Pharmacy Services, Inc. Total Parental Nutrition - Pediatric PN recall: Incorrect product formulation: bag did not contain copper and famotidine
Incorrect product formulation: bag did not contain copper and famotidine per label.
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep FREPP Clear, and 70% v/v isopropyl alcohol 1.5 mL recall: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.