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 kit: IV Start KIT W/Hubguard Dyndv2662 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
Steris Corporation HarmonyAIR A-Series Surgical Lighting System recall: There is a potential for paint delamination (chipping/peeling)
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
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Class I · 4 months ago
Arrow International, LLC Description/REF: Drainage KIT/AK-01600, Drainage KIT/AK-01601 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 I · 4 months ago
Abiomed, Inc. Automated Impella Controller , for use with left heart support blood recall: Potential software error in the Automated Impella Controller ("AIC" )
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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Class I · 4 months ago
Arrow International, LLC Description/REF: PSI KIT: 7 FR X 4IN 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) Carotid Neuro 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 II · 4 months ago
Medline Medical Procedure Kits labeled as: 1) Crani 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 Medical Procedure Kits labeled as Bioburden Test 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
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 II · 4 months ago
Medline Pre-connected Urethral Catheterization Tray and Bag 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
Bd Switzerland Sarl BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code recall: Due to stopcock issues when using the plastic luer-lok syringe
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than…
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Class II · 4 months ago
Medline convenience kits: Basic Dynj905869G Basic Pack Dynj68484B BIB 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
GE Medical Systems, LLC Giraffe OmniBed Field Replaceable Unit recall: GE HealthCare has become aware of a potential issue involving the canopy
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain…
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Class II · 4 months ago
Medline Urethral Catheterization Tray, Red Rubber Latex 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 3/4 IN/TJ-04020-1 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: C Section CDS985505G C Section Pack 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 Urethral Catheterization Tray and Bag, Red Rubber Latex 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
Product Name: STAAR ICL Calculation Software Software Version: Version recall: Due to a software coding issues for calculating the implant orientation
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
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Class I · 4 months ago
Arrow International, LLC Description/REF: CVC KIT: 16 GA X 8IN/AK-04210 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
Howmedica Osteonics Corp. TRI TS Baseplate Size 4 recall: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate…
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Class II · 4 months ago
Medline convenience kits: Inpatient Central LN Drsg KIT Dyndc3525 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 Urethral Catheter, Red Rubber Latex 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 Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers 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 convenience kits: Breast Imaging Dynjt5893 Chog Plastics 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…