Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class III · 10 months ago
Datascope Corp. Cardiosave Rescue recall: The IFU addendum updates the Vibration and Shock Table to reference
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, EP LAB PK recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
GE Healthcare GmbH GE HealthCare ViewPoint 6 recall: GE HealthCare has become aware that the Patient History tab in ViewPoint 6
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete…
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Midtown General Arteriogram recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
Abbott Laboratories Alinity ci-series System Control Module , REF: 03R70-01, 03R70-20 recall: Abbott Laboratories is recalling their Alinity ci-series System Control
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the…
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Class II · 10 months ago
Myofunctional Research Company USA Myosa for Kids KS1 REF MyOsaks1_Sb/Sp/Mb/Mp/Lb/Lc recall: Due to firm mistakenly distributing product within the U.S. without FDA
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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Class II · 10 months ago
Path Madsen Accuscreen Teoae/Dpoae/ABR Probe recall: Following a component change in the DPOAE probe (speaker replacement)
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with…
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Class II · 10 months ago
Mindray North America Hardware configuration of the BeneVision Central Monitoring recall: When the Worstation of the BeneVision DMS has a specific hardware
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen…
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Class II · 10 months ago
Zimmer Air Dermatome, Model/ recall: The devices may have a misaligned thickness control bar
The devices may have a misaligned thickness control bar.
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Class III · 10 months ago
Instrumentation Laboratory HemosIL SynthAFax. Partial Thromboplastin Time Tests recall: Recalled lots were manufactured with double the amount of preservative
Recalled lots were manufactured with double the amount of preservative concentration.
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Class II · 10 months ago
Smith & Nephew, Inc. Biosure HA Screw, 6MM x 20 MM. Threaded metallic bone fixation recall: Removal of affected lot of screws due to labeling error
Removal of affected lot of screws due to labeling error.
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Class II · 10 months ago
Cepheid Brand Name: Xpert¿ BCR-ABL Ultra Model/ recall: Invitro diagnostic test kits with specimens that have elevated white blood
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
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Class II · 11 months ago
C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm recall: Labeling discrepancy; Ureteral stent actual size may not match the actual
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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Class III · 11 months ago
Orthofix U.S. LLC Brand Name: Forza" PTC Spacer System Product Name: Forza" PTC Spacer recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 11 months ago
Orthofix U.S. LLC Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class I · 11 months ago
Draeger, Inc. ErgoStar CM 55, Model/ recall: Multiple complaints were reported in which cracks formed in the hose
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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Class III · 11 months ago
Orthofix U.S. LLC Brand Name: Firebird" SI Fusion System Product Name: Firebird" SI recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class II · 11 months ago
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class II · 11 months ago
Nipro Medical Corporation Hemodialysis System, Surdial DX REF: MC+SDX01 recall: Screw may loosen or fallout of Hemodialysis system
Screw may loosen or fallout of Hemodialysis system
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Class II · 11 months ago
Medline Perfusion Syringe, REF: Dynj39223C recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of…
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Class II · 11 months ago
Waldemar Link GmbH & Co. KG Endo Model Knee Fusion Nail SK, Knee Fusion Nail recall: The device has been delivered with a preassembled locking screw that had
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral…
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Class II · 11 months ago
Medline Industries, LP Dexlock Achilles Repair Implant Kits, Makt4520 recall: There have been multiple complaints of drill bit fusing to the bushing/sleeve
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit…
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Class II · 11 months ago
Stryker MV3 bariatric bed recall: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close…