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All recalls8,517 total

3
3rd Day Beverages LLC — LION Pineapple Spring Water Hydration Drink, 20 fl. oz, packaged in PET bottles, packed 12 per case

Potential contamination with floating objects

3
3rd Day Beverages LLC — LION Lemon Lime Spring Water Hydration Drink, 20 fl. oz, packaged in PET bottles, packed 12 per case

Potential contamination with floating objects

3
3rd Day Beverages LLC — LION Watermelon Spring Water Hydration Drink, 20 fl. oz, packaged in PET bottles, packed 12 per case

Potential contamination with floating objects

3
3rd Day Beverages LLC — LION Mixed Berry Spring Water Hydration Drink, 20 fl. oz, packaged in PET bottles, packed 12 per case

Potential contamination with floating objects

A
AVID Medical, Inc. — DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

O
Orient Pharma Co., Ltd. Yunlin Plant — Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for:

Failed Impurities/Degradation Specifications.

O
Orient Pharma Co., Ltd. Yunlin Plant — Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for:

Failed Impurities/Degradation Specifications.

M
Macleods Pharmaceuticals Ltd — Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

A
AVID Medical, Inc. — LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — CARDIAC ROBOT PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — LAPAROSCOPIC GYN. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — ROBOTIC URO/GYN PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — LAPAROSCOPIC TRAY. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — GYN LAPAROSCOPY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — GENERAL LAPAROSCOPY TRAY. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — GEN LAPAROSCOPY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — LAPAROSCOPY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

C
CooperSurgical, Inc. — Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

A
AVID Medical, Inc. — MAJOR THORACOSCOPY BASIN. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

F
FUJIFILM Healthcare Americas Corporation — ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P1

Devices had an unapproved slabbing software function enabled for use.

A
AVID Medical, Inc. — HVI CARDIAC ROBOT PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

C
CooperSurgical, Inc. — Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

A
AVID Medical, Inc. — GENERAL ROBOTIC PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

C
CooperSurgical, Inc. — HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

A
AVID Medical, Inc. — DAVINCI UROLOGY. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — GS ENDOSCOPY PACK. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — CT DAVINCI. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A
AVID Medical, Inc. — DA VINCI PACK URO/PROSTATE. Medical convenience kit.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

B
Boston Foundation For Sight — BostonSight SCLERAL Lens

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

B
Boston Foundation For Sight — BostonSight PROSE Lens.

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

B
Boston Scientific Corporation — Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduc

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

M
Mightylicious Inc. — MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies Gluten-Free, Dairy-Free, Allergen Friendly, Egg-Free, Non-GMO, Kosher, Preservative-Free Snack Option for a Guilt-Free Treat - 6.5

Undeclared Milk

Y
Yerba Prima Inc — Great Plains Bentonite + Herbal Detox Capsules 60 capsules, packaged in PETE amber bottle, white plastic cap and tamper proof seal. Case GTIN code:100 46352 00518 5. Retail package

Potential contamination with Pseudomonas aeruginosa.

B
Big O' Smokehouse, Inc. — Big O' Smokehouse 4lb Whitefish Spread Big O' Smokehouse 8oz Whitefish Spread Packaged in plastic containers

Foreign material (white plastic) within whitefish spread

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Cacao Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergen - soy

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergens - soy and wheat

H
HOFOOD99 INC. — Enoki Mushroom in a 200g, green and clear plastic package marked with UPC Barcode 6 976532 310051 on the back label; a picture of enoki mushrooms is outlined in green on the front of t

Product may be contaminated with Listeria monocytogenes.

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergen - soy

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Cacao Brownie Bites Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergens - soy and wheat

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Cacao Strawberry Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergen - soy

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Cookies and Cream Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergens - soy and wheat

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Mocha Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergen - soy

T
Turkeyfoot Creek Creamery LLC — Turkeyfoot Creek Creamery Cookie Dough Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Undeclared allergens - soy and wheat

I
IMMUNOCORE, LLC — KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX

Subpotent Drug

B
Boston Scientific Corporation — VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

B
Boston Scientific Corporation — VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

B
Boston Scientific Corporation — VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the perc

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

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