FDA (Devices) recall action 95128
The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
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The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.
Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.
Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.
Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in the US, Canada, and Panama.
Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.
Medline Industries is recalling 1,076 surgical convenience kits due to reported adverse events from potential suction loss during use. Products were manufactured from September to November 2023.
Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.
Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.
Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.
Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.
Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in US, Canada, and Panama.
Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.
Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.
Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.