Recalls and safety alerts from the FDA, newest first.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 400 units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 146,600 units
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. — Lannett Company Inc. · Class II · Ongoing · 1392 bottles
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. — Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · Ongoing · 560 bottles
Reduced or no recovery of some strains of Neisseria gonorrhoeae. — Remel, Inc · Class II · Ongoing · 1573
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
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
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 · 3,240
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
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to out-of-specification, or potential out-of-specification, levels of endotoxins — TELEFLEX LLC · Class II · Ongoing · 1488700
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 · 15662 kits
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough ed… — Masimo Corporation · Class II · Ongoing · 772
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 · 915
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 · 510 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 · 40 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
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. — Carl Zeiss Meditec AG · 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 · 4,936,056 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
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 · 16,887
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 · 48075 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 · 176 kits
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 · 24,348