Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 3 months ago
Kent Imaging, Inc. SnapshotGLO Wound Imaging Device, Model KB100, KB100AA recall: The software controlling the wound imaging device's battery charging circuit
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully…
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Class II · 3 months ago
AVID Medical, Inc. Halyard EYE PACK. Model/ recall: Incorrect concentration of Betadine solution contained within certain AVID
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
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Class II · 3 months ago
Wilcox Industries Corp recall: Wilcox is notifying all customers who have purchased a product from the BOSS
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class I · 3 months ago
Medline Anterior HIP, Medline Kit SKU Dynj909640G recall: Medline Industries, LP is issuing a recall for specific Medline kits
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in…
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Class II · 3 months ago
Paragon 28, Inc. P28 Phanton Intramedullary Nail System, Phantom Hindfoot TTC/TC Ball recall: Paragon 28 received two (2) complaints were received involving breaches
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
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Class II · 3 months ago
Boston Scientific Corporation Farastar PFA Generator, Product ID M004Pfce61M460 recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology recall: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants…
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Class II · 3 months ago
Medtronic Neurosurgery Ventriculostomy Kit, REF: 46154 recall: Ventriculostomy devices, used during ventriculostomy procedures to gain
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed…
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Class II · 3 months ago
Medline medical convenience kits labeled as: 1) Total Joint Pack recall: Medline Industries, LP is issuing a recall for specific Medline convenience
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Medline medical convenience kits labeled as: 1) Shoulder Pack recall: Medline Industries, LP is issuing a recall for specific Medline convenience
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Ferno-Washington Inc Power F2 Powered Fastening System, Product No. 0567091 Powered recall: Product may experience accelerated roller wear and potential deformation
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case…
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Class II · 3 months ago
Boston Scientific Corporation Farastar Pulsed Field Ablation Generator recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1 recall: Flexible hysteroscopes indicated for use during diagnostic and operative
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal…
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Class II · 3 months ago
ICU Medical Inc. Hotline Fluid Warming Set, single use device recall: ICU Medical became aware of an increased likelihood of leakage in specific
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate…
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Class I · 3 months ago
Medline medical procedure convenience kit labeled as: 1) Total Knee-Lf recall: The procedure kits contain ICU Medical, Inc. pain management kits containing
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were…
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Class II · 3 months ago
Boston Scientific Corporation Farastar Ablation Generator EU recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Medtronic MiniMed, Inc. MiniMed Go App, Model: MMT-8600 , MMT-8601 recall: For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the…
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Class II · 3 months ago
Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural recall: Intraoperative neuromonitoring device, due to a software issue
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG)…
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Class II · 3 months ago
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall: Due to manufacturing issues, reperfusion catheters may fractures
Due to manufacturing issues, reperfusion catheters may fractures
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Class II · 3 months ago
AVID Medical, Inc. Halyard Standard Line Insertion Pack. Model/ recall: Defects in the silicone seal, which may result in "doming" of the silicone
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or…