FDA medical device recalls

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.

DePuy Synthes ATTUNE Revision Hinge Knee Housing Components with various crosspin sizes were distributed with packaging defects: the external sterile package was found stuck to the internal sterile package, which may have compromised the sterility of the medical device. Affected units were distributed to Minnesota, North Carolina, and Texas.

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.

A single lot of 10cc Luer Lok syringes (Lot 8298877) with an expiration date that had passed were distributed to hospitals and medical facilities in California, Florida, and Pennsylvania due to a failure in the distribution system's inventory controls. About 1,401 syringes were affected. No injuries have been reported.

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.

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

The nebulizer cup on Hillrom Volara P.Circuit 5Kit devices can leak air and medication if not properly locked during setup. This leakage may reduce oxygen delivery to the patient and prevent the prescribed medication from being delivered effectively.

The nebulizer cup on Hillrom VOLARA System breathing circuits may not lock properly after medication is added, causing air and medication to leak during therapy. This leakage can reduce oxygen delivery to the patient and prevent the prescribed medication from being effectively inhaled.

Medline's Ophthalmic Pack with Lidocaine (Model DYNJ57922A) contains lidocaine ampules manufactured by Huons Co., Ltd. that have quality issues identified during an FDA inspection of the manufacturing facility. About 180 kits were distributed nationwide.

Medline Industries is recalling three models of circumcision procedure kits because they contain lidocaine ampules with quality issues. The ampules were made by Huons Co., Ltd. and problems were found during an FDA manufacturing inspection. No injuries have been reported.

Medline's L&D Continuous Epidural Tray (Model PAIN1699A) contains Lidocaine Ampules that were recalled by the manufacturer, Huons Co., Ltd., due to quality problems found during an FDA inspection. About 432 kits with this component have been distributed nationwide.

Medline's Lumbar Puncture Choice Kit (Model DYNDH1215) contains Lidocaine Ampules manufactured by Huons Co., Ltd. that have quality issues identified during an FDA inspection of the manufacturer's facility. The affected kits were distributed nationwide.

Medline Industries is recalling two medical convenience kits that contain Lidocaine Ampules from Huons Co., Ltd. The Lidocaine was flagged for quality issues during an FDA inspection of the manufacturer's facility. About 250 kits were distributed nationwide.

Multiple Medline medical kits containing lidocaine ampules manufactured by Huons Co., Ltd. are being recalled due to quality issues found during an FDA inspection of Huons' manufacturing facility. The affected kits are used for various surgical and medical procedures including suturing, chest tube insertion, biopsies, and arterial line placement.

Medline Industries has recalled multiple medical procedure kits (central line, arterial line, dialysis, biopsy, and suturing kits) because they contain lidocaine ampules with quality issues. The lidocaine supplier, Huons Co., Ltd., issued a recall after the FDA inspected their manufacturing site and identified problems. No injuries have been reported.

Medline Convenience Kits (Model SUT13710) contain Lidocaine Ampules that were subject to a recall by the manufacturer Huons Co., Ltd. due to quality issues found during an FDA inspection of their manufacturing facility. About 176 kits were distributed nationwide.

Medline's Imaging Biopsy Tray (Model DYNDH1068) and Breast Biopsy Pack (Model PHS234706I) contain lidocaine ampules that were identified as defective during an FDA manufacturing inspection. The ampules were supplied by Huons Co., Ltd. and may not meet quality standards. Approximately 40 kits are affected nationwide.

Medline Convenience Kits containing Huons Lidocaine HCL Injection ampules are being recalled due to quality issues found during an FDA manufacturing inspection. The affected kits include two introducer models (6F and 9F) distributed nationwide. No injuries have been reported.