Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,001–10,050 of 15,364
- Class II
Medical Device Recall · September 24, 2024
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Drug Recall · September 24, 2024
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.Crystallization
- Class II
Medical Device Recall · September 24, 2024
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Drug Recall · September 24, 2024
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., VaPresence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
- Class II
Drug Recall · September 24, 2024
Glenmark Pharmaceuticals Inc., USA
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43Defective Delivery System: The dip tube is clogged causing the spray not to work.
- Class II
Medical Device Recall · September 24, 2024
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Food Recall · September 23, 2024
Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a cardboard box and was not sold toUndeclared Wheat flour. Product contains wheat flour but product was sold without the Ingredients Statement.
- Class II
Medical Device Recall · September 23, 2024
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
- Class II
Medical Device Recall · September 22, 2024
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage SystemPotential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Class II
Medical Device Recall · September 20, 2024
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systemIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervousIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervousIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard ENT - Medical convenience kits Model Number: VMED011-01Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard EP PACK - Medical convenience kits Model Number: VANW018-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sysIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions