United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical c...
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.
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder wi...
Product may be contaminated with Clostridium botulinum.
CRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/0...
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE...
Product may be contaminated with Salmonella Typhimurium
FIRST STREET Dark Chocolate Raisins Net Wt. 9 oz. (255g) UPC 797565011830 INGRE...
Undeclared peanuts.
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Sy...
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
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.
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ...
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
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr...
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
CRE Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
CRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
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.
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...
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
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
CRE Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl a...
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
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, sur...
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.
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG12...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
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.
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat...
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 adding medication during user setup.
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESI...
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.
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog ...
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 adding medication during user setup.