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Medical Device
FDA DevicesClass II

INZONE DETACHMENT SYSTEM, REF: M00345100950

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

Jul 1, 2026Stryker Neurovascular
Vehicle
NHTSAEXTERIOR LIGHTING

Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108

Parking lights and daytime running lights that fail to illuminate properly reduce the vehicle's visibility to other drivers, increasing the risk of a crash.

Jul 1, 2026Chrysler (FCA US, LLC)
Medical Device
FDA DevicesClass II

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, b...

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Jul 1, 2026SURGIFY MEDICAL OY
Pharmaceutical
FDA DrugsClass II

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient speci...

Incorrect product formulation: bag did not contain copper and famotidine per label.

Jul 1, 2026Central Admixture Pharmacy Services, Inc.
Pharmaceutical
FDA DrugsClass II

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60...

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Jul 1, 2026Direct Rx
Medical Device
FDA DevicesClass II

Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs,...

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Jul 1, 2026SURGIFY MEDICAL OY
Medical Device
FDA DevicesClass II

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs...

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Jul 1, 2026SURGIFY MEDICAL OY
Medical Device
FDA DevicesClass II

TMJ Bilateral Implants, REF: CHG020

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Jul 1, 2026TMJ Solutions Inc
Medical Device
FDA DevicesClass II

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, b...

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Jul 1, 2026SURGIFY MEDICAL OY
Pharmaceutical
FDA DrugsClass II

Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: ...

CGMP Deviations

Jul 1, 2026Amgen, Inc.
Pharmaceutical
FDA DrugsClass II

Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL...

sub potency

Jul 1, 2026Elevate Oral Care
les moulinettes - coquillettes lentilles vertes
RappelConsovolontaire (san...

les moulinettes - coquillettes lentilles vertes

taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire

Jul 1, 2026les moulinettes
Food & Beverage
FDA FoodClass I

6/11oz Sunflower Seeds Salted

The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.

Jul 1, 2026George J Howe Company, Inc.
Medical Device
FDA DevicesClass I

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro...

Potential for thrombus formation during prolonged use of the introducer.

Jul 1, 2026Abiomed, Inc.
Food & Beverage
FDA FoodClass I

2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.

Potential presence of Salmonella.

Jul 1, 2026Utz Quality Foods, LLC
Safety Alert
RSS FeedGeneral Alert

Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products

Jul 1, 2026
Food & Beverage
UK FSAPublished

O’Brien Fine Foods recalls ham products because of possible contamination with L...

 The possible presence of Listeria monocytogenes in the products listed above. Symptoms caused by Listeria monocytogenes can be similar to flu and include high temperature, muscle ache or pain, chills, feeling or being sick and diarrhoea. However, in rare cases, the infection can be more severe, causing serious complications, such as meningitis. Some people are more vulnerable to listeria infections, including those over 65 years of age, pregnant women and their unborn babies, babies less than one month old and people with weakened immune systems.

Jul 1, 2026O’Brien Fine Foods
Pharmaceutical
FDA DrugsClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Jul 1, 2026CareFusion 213, LLC
Food & Beverage
FDA FoodClass II

Joy Pineapple Lassi 16 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
Pharmaceutical
FDA DrugsClass II

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I...

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Jul 1, 2026SUN PHARMACEUTICAL INDUSTRIES INC
fabriqué sur place - croissant au jambon
RappelConsovolontaire (san...

fabriqué sur place - croissant au jambon

mise en évidence de la présence de listeria monocytogenes

Jul 1, 2026fabriqué sur place
axel et paul - sorgho biologique décortiqué
RappelConsovolontaire (san...

axel et paul - sorgho biologique décortiqué

la teneur en zéaralénone et la somme de t-2 toxine et de ht-2 toxine

Jul 1, 2026axel et paul
Medical Device
FDA DevicesClass II

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Jul 1, 2026Medline Industries, LP
Medical Device
FDA DevicesClass I

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...

Potential for thrombus formation during prolonged use of the introducer.

Jul 1, 2026Abiomed, Inc.
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