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Medical DeviceUSFDA Devices

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

Philips North America
FDA DevicesClass II

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

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.

May 6, 2026Philips North America
PharmaceuticalUSFDA Drugs

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

Wells Pharma of Houston LLC
FDA DrugsClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
Medical DeviceUSFDA Devices

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

Philips North America
FDA DevicesClass II

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

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.

May 6, 2026Philips North America
PharmaceuticalUSFDA Drugs

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

Wells Pharma of Houston LLC
FDA DrugsClass II

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
Medical DeviceUSFDA Devices

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
FDA DevicesClass II

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.

May 6, 2026Medline Industries, LP
Medical DeviceUSFDA Devices

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

Milestone S.R.L.
FDA DevicesClass II

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

There is a possibility of reagent leakage from the specimen container.

May 6, 2026Milestone S.R.L.
Medical DeviceUSFDA Devices

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Becton Dickinson & Co.
FDA DevicesClass II

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. 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.

May 6, 2026Becton Dickinson & Co.
Medical DeviceUSFDA Devices

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Straumann USA LLC
FDA DevicesClass II

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

May 6, 2026Straumann USA LLC
PharmaceuticalUSFDA Drugs

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

Wells Pharma of Houston LLC
FDA DrugsClass II

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
PharmaceuticalUSFDA Drugs

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

Wells Pharma of Houston LLC
FDA DrugsClass II

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

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.

May 6, 2026Medline Industries, LP
Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U

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.

May 6, 2026Medline Industries, LP
Food & BeverageUSFDA Food

Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.

King Juice Company, Inc.
FDA FoodClass II

Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.

Product contains undeclared Yellow No. 5.

May 6, 2026King Juice Company, Inc.
PharmaceuticalUSFDA Drugs

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

Wells Pharma of Houston LLC
FDA DrugsClass II

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
Food & BeverageUSFDA Food

Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893

HEMU TRADING INC
FDA FoodClass I

Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893

product tested positive for Listeria Monocytogenes.

May 6, 2026HEMU TRADING INC
PharmaceuticalUSFDA Drugs

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

Alcon Research LLC
FDA DrugsClass II

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

May 6, 2026Alcon Research LLC
PharmaceuticalUSFDA Drugs

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

Wells Pharma of Houston LLC
FDA DrugsClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

cGMP deviations.

May 6, 2026Wells Pharma of Houston LLC
Food & BeverageFranceRappelConso

baker ross - rainbow coloured sand bags x7 jouet d'activité de sable

baker ross
RappelConsoGeneral Alert

baker ross - rainbow coloured sand bags x7 jouet d'activité de sable

le produit contient des fibres d'amiante. l'amiante pourrait causer le cancer. type d'opérateur économique auquel la/les mesure(s) a/ont été ordonnée(s): fabricant catégorie de mesure: rappel du produit auprès des utilisateurs finaux date d'entrée en vigueur: 05/03/2026 type d'opérateur économique auquel la/les mesure(s) a/ont été ordonnée(s): fabricant catégorie de mesure: interdiction de la mise sur le marché d'un produit et toute mesure d'accompagnement date d'entrée en vigueur: 05/03/2026

May 6, 2026baker ross
Food & BeverageFranceRappelConso

xiaohong - amazing sand jouet d'activité de sable

xiaohong
RappelConsoGeneral Alert

xiaohong - amazing sand jouet d'activité de sable

le produit contient des fibres d'amiante. l'amiante pourrait causer le cancer. type d'opérateur économique auquel la/les mesure(s) a/ont été ordonnée(s): détaillant catégorie de mesure: rappel du produit auprès des utilisateurs finaux date d'entrée en vigueur: 05/03/2026 type d'opérateur économique auquel la/les mesure(s) a/ont été ordonnée(s): détaillant catégorie de mesure: interdiction de la mise sur le marché d'un produit et toute mesure d'accompagnement date d'entrée en vigueur: 05/03/2026

May 6, 2026xiaohong
ferme baracand - picodon
RappelConsovolontaire (san...

ferme baracand - picodon

contamination e.coli stec

May 6, 2026ferme baracand
e.leclerc angoulême - filet de maquereau sous vide
RappelConsovolontaire (san...

e.leclerc angoulême - filet de maquereau sous vide

ce rappel fait suite à un prélèvement non conforme sur le taux d'histamine du produit.

May 6, 2026e.leclerc angoulême
Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

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.

May 6, 2026Medline Industries, LP
salaisons jouvin - merguez bœuf volaille halal
RappelConsovolontaire (san...

salaisons jouvin - merguez bœuf volaille halal

présence de salmonelle

May 6, 2026salaisons jouvin
PharmaceuticalUSFDA Drugs

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

Alcon Research LLC
FDA DrugsClass II

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

May 6, 2026Alcon Research LLC
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