Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
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Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
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Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
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Class II · 10 months ago
Intuitive Surgical, Inc. da Vinci 5, Surgeon Console Column Motor Connector recall: Surgical system Error 23062 due to connector1) Partially damaged "Potential
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable…
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Class II · 10 months ago
Brand Name: Diasol Product Name: 100220-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
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Class II · 10 months ago
Brand Name: Diasol Product Name: 100225-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
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Class II · 10 months ago
Brand Name: Diasol Product Name: 100425-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
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Class II · 10 months ago
Microbiologics Inc Kwik-Stik 2-Pack, Campylobacter jejuni subsp. jejuni derived recall: Affected units may fail to recover the target microorganism Campylobacter
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
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Class II · 10 months ago
Cook Incorporated Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) recall: Cook Medical identified that products supplied in the affected device lots
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may…
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Class I · 10 months ago
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer recall: A certain component of affected devices was not delivered within
A certain component of affected devices was not delivered within specification and contained impurities.
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Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Howmedica Osteonics Corp. The Stryker CranialMask Tracker is a single-use device recall: When the device is activated during surgery
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this…
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Class II · 10 months ago
ICU Medical, Inc. LifeShield Drug Library Management recall: For certain customers, the Change Summary review option ceases to operate
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been…
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Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
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Class II · 10 months ago
Medtronic Neuromodulation Restore Clinician Programmer Application recall: Software issue where a Device Reset message displayed on the app was unable
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume…
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Class II · 10 months ago
CareFusion 303, Inc. BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer recall: Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to…
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Class II · 10 months ago
Gold Star Distribution All FDA-regulated products held at facility including drugs recall: Potential Salmonella contamination, presence of rodent and avian
Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process.
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 18Fg 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 I · 10 months ago
GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system Power recall: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
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Class II · 10 months ago
AVID Medical, Inc. Halyard, General Laparoscopy Pack recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Gluteal Implant Product Name: Gluteal Implant recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…