FDA Recalls
Page 11 of 24 · 1,199 total recalls
Recalls — Page 11

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Medtronic Sphere-9 Catheter
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients...

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code:
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for...

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code:
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

ARROW
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

FLEXTIP PLUS EPIDURAL CATHETER
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code:
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for...

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code:
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for...

Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Nuts.com
Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not...

Arjo Tenor mobile passive patient lift
An internal component of the actuators in a certain production batch may not meet the required mechanical strength....

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl,...

VACUUM BAG SU LARGE
There is a possibility of reagent leakage from the specimen container.

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number:
Due to complaints of device breakage at the traction force gauge to handle joint.

LSL Healthcare Wound Closure Tray
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled...

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Philips Spectral CT on Rails.
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the...

Gorditas de Azucar UPC 860010238134
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Doraditas de Azucar UPC 5901234123457
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

MID EAST Jordanian Zaatar spice mix; NET Wt.
Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.

Semaglutide-Glycine-Cyanocobalamin Injectable
Lack of Assurance of Sterility

CUSA Clarity C7000 Console
Software issue that renders the touch screen unresponsive.

The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights.
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly...

The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly...

" Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling
Foreign Object (Glass)

" Dumpling Party Tray (20pcs) Vegetable 13 oz 011110661173 " Dumpling Party Tray (40pcs)
Foreign Object (Glass)

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility

COOK MEDICAL Arterial Pressure Monitoring Tray
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Montebianco
Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels...

Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Item 5650233 Trader Joe's Vegetable Fried Rice, net wt.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.