Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Medline and Centurion | Convenience kits | Medical Devices | The potential for a lack of sterility | Medline Industries, LP | … LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline … branded convenience kits containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation … | ||
| Covidien and Cardinal Health | Expanded list of Urology and OR room specific kits and trays | Medical Devices | Potential lack of sterility assurance which could result in non-sterile product | Cardinal Health | … Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays On … operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP … | ||
| Aligned Medical Solutions | Convenience kits containing saline | Medical Devices | Product cannot be verified as having the required sterility assurance level | Aligned Medical Solutions | … level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation … | ||
| Busse Hospital Disposals | Medical Device Kits and Trays | Medical Devices | Device & Drug Safety - Potential Lack of Sterility | Busse Hospital Disposals | … to Nurse Assist LLC’s , November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility … | ||
| Covidien and Cardinal Health | Urology and OR room specific kits and trays | Medical Devices | Potential lack of sterility assurance which could result in non-sterile product | Cardinal Health | … Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and … operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP … |