2021 Product Recalls

4,623 recalls issued in 2021.

4,623
Total Recalls
63
USDA
219
CPSC
1,016
FDA Drug
USDA 63 CPSC 219 FDA Drug 1,016 FDA Device 1,052 NHTSA 1,093 FDA Food 1,180

Showing 41–60 of 4,623 recalls

FDA Class II

two-bite vanilla & chocolate cupcakes 10.5 oz. UPC 7 70981 03468 3 Sweet P's Bake Shop chocolate & vanilla cupcakes 10.5 oz. UPC 0 11225 54723 2

Potential for metal in product
FDA Class II

Signature Select Pumpkin Spice mini cupcakes 10 oz. UPC 0 21130 98478 7 Bake Shop Pumpkin Spice mini cupcakes 10 oz. UPC 4 09910 02729 56 two-bite Pumpkin Spice cupcakes 10 oz. UPC 7 70981 05551 0

Potential for metal in product
FDA Class II

Cesarina Cookies, Sesame Seed Cookies, Net Weight 16oz (453.59g)

Undeclared Milk
FDA Class II

Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. UPC 0 78742 37635 6

Potential for metal in product
FDA Class II

DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement

Undeclared fish allergen
FDA Class III

Black Rifle Coffee Mac V Whole Bean Coffee 12oz PET bags 40 bags per case

Possible plastic within final product packaging.
FDA Class II

two-bite vanilla cupcakes 10 oz. UPC 7 70981 03460 7 Horneaditos cupcake de vainilla 10 oz. UPC 7 70981 04125 4

Potential for metal in product
FDA Class II

Sprite; 12 oz. aluminum can; 12-pack fridge pack/case

Potential presence of foreign matter in container.
USDA

FSIS Issues Public Health Alert for Ineligible Imported Meat and Poultry Products from China

Import Violation
FDA

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD,

To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

On 10/15/21 correction notices were mailed to customers. Customers were asked to do the following: 1) Ensure all personnel in your organization review this letter and the current instructions for use. If you have previously sold or transferred affected devices to a third party, please forward this notice to all such third parties. 2) Discard any prior versions of the instructions for use. 3) Complete and return the acknowledgment form. Customers with medical or safety-related inquiries can contact Medical Affairs at 1-800-649-8852 or medicalaffairs@karlstorz.com. Customers with questions about the correction communication are encouraged to call 1-866-913-0667 or email karlstorz7824@stericycle.com.
FDA

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

On 09/02/21, Microsoft "PrintNightmare" Vulnerability notices were sent to customers informing them of the upcoming software patches to remediate the vulnerability. This notice was posted on the recalling firm's website in the Security Advisories section. On 10/21/21 correction notices started being sent to customers. Customers were informed that Technical Service Representatives would contact then to schedule installation of the Windows OS patch. Customers were asked to do/ensure the following: 1) Complete the customer reply form, 2) To safeguard patients form potential harm and to inform them what to do in the event of product malfunction, customers were directed to specific parts of the Instructions for Use. 3) Confirm all measurements against baseline pre-operative manifest refraction and do not proceed when outside of recommended limits of difference, for sphere, cylinder and axis, as specified in the operators manual and training material. 4) Maintain manual records of patient measurements. 5) Ensure you comply with obligations under applicable privacy laws relating to putting in place safeguards in connection with personal information for patients. Customers with additional questions were encouraged to call Technical Support at 1 (800)- 511-0911.
FDA Class II

Marketside strawberry shortcake cupcakes 11.7 oz. UPC 6 81131 24844 0

Potential for metal in product
FDA Class II

Kimberley's bakeshoppe Christmas cupcakes with rings 22 oz. UPC 7 70981 31188 3

Potential for metal in product
FDA Class II

two-bite chocolate cupcakes 10 oz. UPC 7 70981 04470 5

Potential for metal in product
FDA Class II

Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 16 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00117 0. Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 32 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00116 3. Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 64 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00123 1. The Ingredients statement

Inhibitory substance was detected.
FDA Class II

Hacienda Las Glorias Premium, Bebida de Parcha (Passion Fruit Drink) 16 Oz. (480 ML)

Undeclared Yellow #5
FDA Class II

two-bite vanilla cupcakes 10 oz. UPC 7 70981 03109 5 284 g UPC 7 70981 73109 4 Bakery Fresh Goodness mini vanilla cupcakes 10 oz. UPC 0 11110 18230 2 NL Vanilla cupcakes 12PK - Everyday 03540 7.52 lbs. case UPC 1 07 70981 03540 3 7 Select vanilla mini cupcakes 10 oz. UPC 0 52548 62682 2 Best Choice Bakery vanilla two-bite cupcakes 10 oz. UPC 0 70038 66154 2 Sweet P's bake shop vanilla cupcakes 10 oz. 0 11225 12601 7 Freshness Guaranteed vanilla cupcakes 13.1 oz. UPC 0 78742 36760 6 Kimber

Potential for metal in product
FDA Class II

two-bite unicorn cupcakes 10 oz. UPC 7 70981 04417 0 Marketside unicorn cupcakes 10 oz. UPC 6 81131 10125 7

Potential for metal in product
FDA Class II

Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged in 64 oz glass bottle with a green cap, Refrigerated, UPC8 97605 00102 6. Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged in 32 oz glass bottle with a green cap, Refrigerated, UPC 8 97605 00105 7.

Inhibitory substance was detected.
FDA Class II

Cesarina Cookies, Fiochetto, Apricot Raspberry Guava, Net Weight 16oz (453.59g)

Undeclared Milk