Recalls and safety alerts from the FDA, newest first.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 310
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 29,490
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after ad… — Baxter Healthcare Corporation · Class I · Ongoing · 16187 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 333 kits
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 1,512 kits
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. — RAYSEARCH LABORATORIES AB · Class II · Ongoing · 3 units
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. — Siemens Medical Solutions USA, Inc · Class II · Ongoing · 57 units
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication. — Medela Inc · Class II · Ongoing · 82900
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 624
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. — Covidien LLC · Class II · Ongoing · 293,659 devices
A single lot of expired syringes were distributed due to a distribution system control failure. — Mentor Texas LP · Class II · Ongoing · 1401 syringes
Due to catheter separation — W L Gore & Associates, Inc. · Class II · Ongoing · 467 devices
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 5,698 kits
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal t… — Hamilton Medical AG · Class I · Ongoing · 27,270 pcs
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 66
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. — Accuray Incorporated · Class II · Ongoing · 292 units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables. — Baxter Healthcare Corporation · Class II · Ongoing · 13 units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due t… — Insulet Corporation · Class I · Ongoing · 1,790,784 units