Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesBD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
FDA Devicesi-STAT EG7+ cartridge; List Number: 03P76-25;
i-STAT EG7+ cartridge; List Number: 03P76-25;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA DrugsfentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
cGMP deviations.
FDA DevicesPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA DevicesMedline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesPhilips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
RappelConsocentre e. leclerc alsedis zi nord 67600 sélestat - blanquette ** a mijoter
centre e. leclerc alsedis zi nord 67600 sélestat - blanquette ** a mijoter
date limite de consommation erronée : 29/05/2026 indiquée au lieu de 29/04/2026
RappelConsocentre e. leclerc alsedis zi nord 67600 sélestat - roti de porc economique echine ou filet a rotir
centre e. leclerc alsedis zi nord 67600 sélestat - roti de porc economique echine ou filet a rotir
date limite de consommation erronée : 30/05/2026 indiquée au lieu de 30/04/2026
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA DevicesAIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
FDA Devicesi-STAT G3+ cartridge; List Number: 03P78-26;
i-STAT G3+ cartridge; List Number: 03P78-26;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesHeraeus, PALAMIX uno. Material Number: 66057893.
Heraeus, PALAMIX uno. Material Number: 66057893.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
FDA DevicesBrand Name: Leksell Vantage Arc System REF: 1053958
Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
FDA DevicesPhilips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA DevicesDimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
FDA DevicesCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
RappelConsogermline - graines germées biologiques alfalfa
germline - graines germées biologiques alfalfa
présence de listéria monocytogène
FDA DevicesMedline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12; 5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775; 7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12; 8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 9. IV START KIT, Medline Kit SKU IV8675; 10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12; 5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775; 7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12; 8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 9. IV START KIT, Medline Kit SKU IV8675; 10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
RappelConsoherta - lardons fumés
herta - lardons fumés
en raison d'une détection de présence isolée de salmonella sur un lot de lardons fumés 200g+25%, et bien qu'étant un produit à cuire, la société herta procède au rappel des lots indiqués
RappelConsoles délices du chaudron - dessert poire vanille
les délices du chaudron - dessert poire vanille
présence de corps étranger métallique