FDA (Devices) recall action 82026
The FDA (Devices) publishes a recall like this one as 20 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 20 pages.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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.
Cook Inc. is recalling 13,388 Wire Guide units because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.
Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.
Cook Inc. is recalling 146 Heavy Duty PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling 3,929 PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling Universa Firm Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.
Cook Inc. is recalling Sof-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.
Cook Inc. is recalling Percutaneous Pigtail Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.
Cook Inc. is recalling Bander Ureteral Diversion Open-End Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling 13,388 Percutaneous Entry Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.
Cook Inc. is recalling Roadrunner Hydrophilic PC Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling Bentson PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
Cook Inc. is recalling 13,388 Percutaneous Malecot Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling Universa Soft Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
Cook Inc. is recalling 15 units of Fixed Core Straight Safety Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients.