Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 4 months ago
Medline convenience kits: Hysterectomy Pack-Lf Dynj20485L recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class I · 4 months ago
Arrow International, LLC Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline convenience kits: BIB AV Fistula Pack Dynj58304B Cardiac Minor recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Thoratec LLC Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery recall: Due to 11 volt Backup Battery failures
Due to 11 volt Backup Battery failures.
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Class I · 4 months ago
Arrow International, LLC Description/REF: Biopsy System Comprehensive KIT/ASK-09458-AH recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline convenience kits: Add-A-Cath Arterial Insertion Artnc185 PED recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: 1) D AND C Pack recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class I · 4 months ago
Arrow International, LLC Description/REF: Access Tray/ASK-04001-Suh-S recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Mito Red Light, Super Mobile recall: The near-infrared therapy device contains a lithium-ion battery
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: 1) BR L&D Pack recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class I · 4 months ago
Arrow International, LLC Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as Basic GYN, CW LAP GYN recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class I · 4 months ago
Arrow International, LLC Description/REF: Pacing/PSI KIT: 5 FR 2L/ASK-07155-MGU recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Steris Corporation HarmonyAIR A-Series Surgical Lighting System recall: The the plus and minus buttons (+/-) used to control light intensity
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
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Class II · 4 months ago
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless recall: Potential for overpressure alerts
Potential for overpressure alerts.
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Class I · 4 months ago
Arrow International, LLC Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline CCI Nerve Block Tray Dynjra2742 Medline Cpnb Dynjra2716 recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class I · 4 months ago
Arrow International, LLC Description/REF: Peritoneal Lavage Cath KIT:8FR/AK-09000 recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: 1) KIT Urology recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class I · 4 months ago
Datex-Ohmeda Inc Giraffe Warmer with Integrated Resuscitation System recall: Blender knob shaft can loosen, which can affect the delivered oxygen
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: Nursing KIT recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class II · 4 months ago
Medline convenience kits: Breast-Hernia-Port Cds-Lf CDS984853L recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class I · 4 months ago
Datex-Ohmeda Inc Giraffe Stand-alone Infant Resuscitation System recall: Blender knob shaft can loosen, which can affect the delivered oxygen
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not…
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Class I · 4 months ago
Arrow International, LLC Description/REF: Hemodialysis KIT: 2-Lumen 12 FR X 16 recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…