Sterility concerns medical devices recalls
12 FDA Class I medical devices recall events since Jan 1, 2025 whose stated reason matches “Sterility concerns”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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AVID Medical, Inc. medical device recall: Haylard 18G SINGLE SHOT EPI TRAY
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
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Medline Industries, LP medical device recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of…
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Medical Action Industries, Inc. 306 medical device recall: Kit: Epidural/Pain TQC 20/Cs
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
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Spectra Medical Devices, Llc medical device recall: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium…
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to…
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Argon Medical Devices, Inc medical device recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode…
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
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Windstone Medical Packaging, Inc. medical device recall: A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine…
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Arrow International, LLC medical device recall: Paracentesis Kit
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 quality issues and…
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Alcon Research LLC medical device recall: Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
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Medline Industries, LP medical device recall: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F
Convenience kits labeled as sterile have not gone through the sterilization process.
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: MicroMyst Applicator
Lack of sterility assurance.
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: Extended Tip Applicator
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
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Avanos Medical, Inc. medical device recall: Brand Name: Ballard Product Name: Closed Suction Catheters…
Lack of sterility assurance for closed suction catheter systems