United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical...
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.
CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami...
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 ...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; ...
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.
CRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
CRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOF...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
ARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017410...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only,...
Subpotent Drug
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder wi...
Product may be contaminated with Clostridium botulinum.
CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULT...
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 Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT...
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.
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401...
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
CRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage ...
Potential contamination with plastic material
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release ...
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.
MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net ...
Potential contamination with plastic material
CRE Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun...
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.