New Hampshire recalls

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Boston Scientific Corporation is recalling certain CRE Pro Wireguided catheters (18–20 mm, 240 cm) due to a potential sterile breach in the packaging pouches. The breach could compromise the sterility of the devices before use. This affects approximately 81,543 units distributed worldwide.

Boston Scientific has recalled CRE Pro Wireguided catheters (15–18mm, 240cm) because some packaging pouches may have a sterile breach. This affects specific lot numbers distributed worldwide. No injuries have been reported.

Boston Scientific recalled certain CRE Pro Wireguided catheters (12–15 mm, 240 cm) due to a potential breach of the sterile packaging pouches. Affected units were distributed worldwide and have expiration dates between November 2028 and March 2029. The company has not reported any injuries related to this issue.

Boston Scientific Corporation is recalling CRE Pro Wireguided catheters (10–12 mm, 240 cm) because the sterile packaging pouches may have been compromised. This affects over 81,000 units distributed worldwide. The breach could allow contamination of the device before use.

Boston Scientific has recalled certain CRE Pro Wireguided catheters (8–10 mm, 240 cm) because the sterile pouches protecting these devices may have been breached during manufacturing or packaging. A breached sterile barrier could allow bacteria or other contamination to reach the device before use. The recall affects 81,543 units distributed worldwide.

Boston Scientific identified a potential sterile breach in the packaging of certain CRE Pro Wireguided 6-8mm 240cm catheters. The devices may have been exposed to contamination during packaging. No injuries have been reported.

The IntelliCuff portable cuff pressure controller may display a "Cuff System Leakage" error and cause the motor to pump continuously instead of maintaining the pressure set by the user. This can prevent the device from working as intended.

Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Windstone Medical's AMS Preop Kit-NS surgical convenience kits contain Webcol Large Alcohol Prep Pads that were recalled due to bacterial contamination (Paenibacillus phoenicis) discovered during sterilization testing. The contamination was identified by Cardinal Health, the pad manufacturer. About 200 kits with specific lot codes are affected.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Medacta's Short Monobloc Stem Broaches (sizes 7–16), used during shoulder replacement surgery, have a manufacturing issue that causes the surgical instruments to be positioned slightly off-center during the procedure. This misalignment may increase the risk of fractures in the upper arm bone.

Certain lots of DePuy Synthes ATTUNE Revision Hinge Knee Insert components were found with external sterile packaging adhered to the internal sterile packaging. This contact may have compromised the sterility of the surgical implant inside.

Specific lots of Medline reprocessed St. Jude Medical Response diagnostic electrophysiology catheters may contain small particles of residual material on surfaces that contact patients. If these particles dislodge during use, they could potentially cause blood clots, inflammation, or infection.

Medline Convenience kits contain Swan-Ganz catheters with a defective blue hub that can leak, break, or damage the lumen. This defect may cause leakage of medication, loss of blood, or infection during cardiac surgery.

Medline Convenience kits contain Swan-Ganz catheters with a defective blue hub on the proximal injectate lumen that can leak, break, or damage the lumen. This defect can lead to leakage during use, loss of medication, blood loss, or infection.

Medline's Convenience kits contain Swan-Ganz catheters that were recalled by manufacturer Becton Dickinson due to failures in the blue proximal injectate lumen hub. These failures can cause leaks, lumen damage, and breakage, which may result in infection, medication loss, or blood loss.

Medline Convenience kits contain Swan-Ganz catheters manufactured by Becton Dickinson (BD) that have a defect in the blue proximal injectate lumen hub. The hub can leak, break, or fail, potentially causing medication loss, blood loss, or infection during use.

Medline Convenience kits contain Swan-Ganz catheters manufactured by Becton Dickinson (BD) that may leak or break due to a defect in the blue proximal injectate lumen hub. The defect can cause leakage, lumen damage, breakage, and potential infection, medication loss, or blood loss during use.

Medline Convenience kits contain Swan-Ganz catheters that were recalled by manufacturer Becton Dickinson due to failures in the blue proximal injectate lumen hub. These failures can cause leaks, lumen damage, and breakage, potentially leading to infection, medication loss, or blood loss.

Medline Convenience kits contain Swan-Ganz catheters with a defective connector (blue hub) that can leak, break, or damage the internal lumen. This defect may lead to medication loss, blood loss, or infection during medical use.

Medline Convenience kits contain Swan-Ganz catheters with a defective blue hub that can leak, break, or damage the lumen. This defect may cause medication loss, blood loss, or infection during use.

Some Omnipod Eros pods may have damage to the soft cannula (the tiny tube that delivers insulin) caused during manufacturing. This damage can cause insulin to leak outside the pod instead of being delivered into your body. If insulin isn't delivered properly, blood glucose levels can rise to dangerous levels.

Some Omnipod DASH Pods have a manufacturing defect in the soft cannula (the tiny tube that delivers insulin) that can cause insulin to leak around the pod instead of into your body. This means you may receive less insulin than needed, which can lead to high blood sugar levels.

Some Omnipod 5 insulin pump pods have a manufacturing defect in the soft cannula (the small tube that delivers insulin) that can cause insulin to leak outside the pod instead of being delivered into the body. This under-delivery of insulin can lead to high blood sugar levels. In severe cases, prolonged high blood sugar can result in diabetic ketoacidosis or other serious complications.

The nebulizer cup on Hillrom VOLARA System patient circuits may not lock properly during setup, allowing air and medication to leak during therapy. This leakage can reduce oxygen delivery to the patient and prevent medication from being administered as prescribed.