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Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I

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: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.

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

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

Philips North America
FDA DevicesClass II

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, 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.

May 6, 2026Philips North America
Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

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 & BeverageFranceRappelConso

1. land rover 2. range rover - range rover sport (lw), range rover evoque (lv) voiture particulière

1. land rover 2. range rover
RappelConsoGeneral Alert

1. land rover 2. range rover - range rover sport (lw), range rover evoque (lv) voiture particulière

le déploiement du gonfleur au nitrate d'ammonium peut provoquer son éclatement lorsqu'il y a eu dégradation du propulseur. une telle rupture du gonfleur peut entraîner la projection de fragments métalliques à grande vitesse à travers l'airbag à l'intérieur du véhicule, ce qui peut entraîner des blessures graves et même mortelles pour les occupants.

May 6, 20261. land rover 2. range rover
Medical DeviceUKUK

Field Safety Notices: 1 May 2026

MHRAUK
uk-mhraMedical Device ...

Field Safety Notices: 1 May 2026

List of Field Safety Notices for 1 May 2026....

May 6, 2026MHRA
Medical DeviceAustraliaAustralia

TGA warning on the risks of importing unapproved peptide products

TGAAustralia
au-tgaMedical Device ...

TGA warning on the risks of importing unapproved peptide products

We are warning consumers about the risks of importing and using unapproved peptide products that are promoted online....

May 6, 2026TGA
Food & BeverageUSFDA Food

My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8

The Mochi Ice Cream Company, LLC
FDA FoodClass II

My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8

Foreign object found inside retail container.

May 6, 2026The Mochi Ice Cream Company, LLC
Medical DeviceUSFDA Devices

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Zimmer, Inc.
FDA DevicesClass II

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

May 6, 2026Zimmer, Inc.
Medical DeviceUSFDA Devices

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Siemens Healthcare Diagnostics, Inc.
FDA DevicesClass II

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

May 6, 2026Siemens Healthcare Diagnostics, Inc.
Medical DeviceUSFDA Devices

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).

North American Rescue LLC.
FDA DevicesClass I

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.

May 6, 2026North American Rescue LLC.
Food & BeverageUSFDA Food

52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1

Guangdong Zonegoing Food Co., LTD
FDA FoodClass II

52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

May 6, 2026Guangdong Zonegoing Food Co., LTD
Medical DeviceUSFDA Devices

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B

Medline Industries, LP
FDA DevicesClass II

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.

May 6, 2026Medline Industries, LP
Medical DeviceUSFDA Devices

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Merit Medical Systems, Inc.
FDA DevicesClass II

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

catheter may experience resistance when being advanced over the guidewire

May 6, 2026Merit Medical Systems, Inc.
germline - graines germées biologiques alfalfa
RappelConsovolontaire (san...

germline - graines germées biologiques alfalfa

présence de listéria monocytogène

May 6, 2026germline
palais des mets - saumon fumé bio
RappelConsovolontaire (san...

palais des mets - saumon fumé bio

présence de listeria monocytogenes dans le produit

May 6, 2026palais des mets
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
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
Medical DeviceUSFDA Devices

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

Boston Scientific Corporation
FDA DevicesClass I

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

May 6, 2026Boston Scientific Corporation
herta - lardons fumés
RappelConsovolontaire (san...

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

May 6, 2026herta
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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F

Medline Industries, LP
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F

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
les délices du chaudron - dessert poire vanille
RappelConsovolontaire (san...

les délices du chaudron - dessert poire vanille

présence de corps étranger métallique

May 6, 2026les délices du chaudron
sophie la girafe - tuyaux folies
RappelConsovolontaire (san...

sophie la girafe - tuyaux folies

présence d’un petit élément susceptible de se détacher après un choc, pouvant être ingéré par un jeune enfant.

May 6, 2026sophie la girafe
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