Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,201–13,250 of 15,379
- Class I
Medical Device Recall · March 14, 2024
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340;Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
- Class II
Medical Device Recall · March 14, 2024
MEDLINE INDUSTRIES, LP - Northfield
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Class II
Medical Device Recall · March 14, 2024
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
- Class II
Medical Device Recall · March 14, 2024
MEDLINE INDUSTRIES, LP - Northfield
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Class II
Medical Device Recall · March 14, 2024
MEDLINE INDUSTRIES, LP - Northfield
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Class II
Medical Device Recall · March 14, 2024
MEDLINE INDUSTRIES, LP - Northfield
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b.Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Class II
Medical Device Recall · March 13, 2024
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - iReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
- Class II
Medical Device Recall · March 13, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens MaPotential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
- Class I
Medical Device Recall · March 13, 2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb MarkerSafety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
- Class II
Medical Device Recall · March 13, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
- Class II
Medical Device Recall · March 13, 2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealedPossible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
- Class II
Medical Device Recall · March 13, 2024
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fortReceived complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
- Class II
Medical Device Recall · March 13, 2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
- Class II
Medical Device Recall · March 12, 2024
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 3.0TX for PET, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Drug Recall · March 12, 2024
Hikma Pharmaceuticals USA Inc.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Class II
Medical Device Recall · March 12, 2024
Ingenia 1.5T S, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 1.5T Conversion, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia 1.5T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 1.5T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Omni/Stellar, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 3.0T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 1.5T Initial, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T R11, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
GYROSCAN T10-NT, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia 3.0T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia Ambition S, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 3.0T Quasar Dual, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Achieva Nova, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Evolution Upgrade 3.0T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class I
Food Recall · March 12, 2024
Kick Ash Products, Door County Love Dark Chocolate Cherry Granola, 1lb, laminated resealable bagUndeclared allergen (almond) in Dark Chocolate Cherry Granola
- Class II
Medical Device Recall · March 12, 2024
Intera 1.0T Omni/Stellar, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Master/Nova, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
GYROSCAN ACS-NT, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 6008Products have a lack of sterility assurance.
- Class II
Medical Device Recall · March 12, 2024
Achieva XR, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia Elition S, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Unclassified
Vehicle Recall · March 12, 2024
2024 KENWORTH T880, 2024 PETERBILT 548, 2024 PETERBILT 567, 2024 PETERBILT 389, 2025 PETERBILT 567A loss of steering control increases the risk of a crash.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
SmartPath to dStream for 1.5T, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia 1.5T CX, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera CV, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Achieva 3.0T for PET, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Unclassified
Vehicle Recall · March 12, 2024
2023 NOVA BUS LFSIncorrectly located attachment points may prevent the securement system from adequately restraining the occupant, increasing the risk of injury during a crash.
- Class II
Medical Device Recall · March 12, 2024
MR 5300, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.
- Class II
Medical Device Recall · March 12, 2024
Ingenia Ambition X, Magnetic Resonance System.Patient support table floor plate may be incorrectly installed.