The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
165
High
268
Moderate
204
Low
33

Of the 688 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

Which agencies issued them

301–400 of 688

  • HighFDA (Food)·F-2171-2014·2014-07-16

    Bazzini Recalls Barricini Milk Chocolate Peanut Butter Pretzels Due to Undeclared Wheat

    Bazzini Holdings is recalling Barricini Milk Chocolate Peanut Butter Pretzels because some containers have incorrect labels that fail to declare wheat.

    Product
    Barricini Milk Chocolate Peanut Butter Pretzels in Net Wt 6.5 oz. plastic tub, UPC 075655235181 Back Panel: Milk Chocolate Peanut Butter Cups Barricini Manufactured by Bazzini Holdings, LLC Allentown, PA 18106
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14E041000·2014-07-16

    Ricon Recalls Wheelchair Lifts Due to Platform Side Plate Cracking Risk

    Ricon is recalling specific wheelchair lift models because the platform side plate may crack, potentially causing the platform to fall and injure the operator.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2111-2014·2014-07-16

    Lemon Cream Raspberry Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Lemon Cream Raspberry Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Lemon Cream Raspberry Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2098-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Banana Puddin' Y'all Ice Cream because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1999-2014·2014-07-16

    Mizuho Doppler Probe Recalled Due to Sterile Barrier Penetration

    Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.

    Product
    07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2165-2014·2014-07-16

    Chocolate Squared Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Chocolate Squared Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Chocolate Squared Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2121-2014·2014-07-16

    Blueberry French Toast Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Blueberry French Toast with Bacon Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Blueberry French Toast with Bacon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2118-2014·2014-07-16

    Banana Nana Fofana Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Banana Nana Fofana Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Banana Nana Fofana Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2000-2014·2014-07-16

    Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration

    Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.

    Product
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2002-2014·2014-07-16

    3M Attest Auto-reader Recalled for Missing Dry Natural Rubber Labeling

    3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.

    Product
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2122-2014·2014-07-16

    Bonjour Toast Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bonjour Toast Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Bonjour Toast Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2162-2014·2014-07-16

    Sunnyside Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Sunnyside Ice Cream because the bulk product lacked labels declaring ingredients and allergens.

    Product
    Sunnyside Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14E042000·2014-07-16

    Trans National Trading Recalls Outlaw T-70 XL Motorcycle Helmets

    Trans National Trading is recalling 486 Outlaw T-70 XL motorcycle helmets manufactured in August 2012 because they fail to comply with federal safety standards.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2014·2014-07-16

    Hospira MedNet Software Recall for Dosing Unit Transmission Defect

    Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.

    Product
    The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2145-2014·2014-07-16

    Rocky Road Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Rocky Road Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Rocky Road Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2149-2014·2014-07-16

    Watermelon Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Watermelon Sorbet because the product lacked required ingredient and allergen labels, including facility processing warnings.

    Product
    Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2101-2014·2014-07-16

    Bourbon Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Ice Cream because the product lacked required ingredient statements and allergen declarations.

    Product
    Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2136-2014·2014-07-16

    Hazelnut Crunch Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Hazelnut Crunch Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Hazelnut Crunch Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2102-2014·2014-07-16

    Bourbon Maple Walnut Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Maple Walnut Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2139-2014·2014-07-16

    Mexican Chocolate Ole Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mexican Chocolate Ole Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2097-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Say "Cheeeeeesecake" Ice Cream because bulk product lacked labels declaring ingredients and direct allergens.

    Product
    Say "Cheeeeeesecake" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2026-2014·2014-07-16

    Steris 4085 General Surgical Table Recalled for Pressure Switch Defect

    Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.

    Product
    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2138-2014·2014-07-16

    Java Chip Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Java Chip Ice Cream because bulk products lacked labels declaring ingredients and allergens.

    Product
    Java Chip Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2158-2014·2014-07-16

    FDA Recalls Cookie Monster Dough Ice Cream for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Cookie Monster Dough Ice Cream because bulk products lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Cookie Monster Dough Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2025-2014·2014-07-16

    CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.

    Product
    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2152-2014·2014-07-16

    Mocha Almond Fudge Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mocha Almond Fudge Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2150-2014·2014-07-16

    Simply Southern Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Simply Southern Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2094-2014·2014-07-16

    Cake Batter Up Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Cake Batter Up Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2134-2014·2014-07-16

    Gin and Juice Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Gin and Juice Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14V430000·2014-07-16

    Tiffin Allegro Bus Recalled for Defective Seat Belt Attachments

    Tiffin is recalling 2013 Allegro Bus vehicles because seat belts may be incorrectly attached and fray, reducing their strength and increasing injury risk in a crash.

    Product
    TIFFIN — TIFFIN ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2099-2014·2014-07-16

    Black Raspberry Chip Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Black Raspberry Chip Ice Cream because bulk product lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Black Raspberry Chip Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2144-2014·2014-07-16

    Raspberry Lemonade Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Raspberry Lemonade Sorbet because the product lacked required ingredient and allergen labels, including facility processing information.

    Product
    Raspberry Lemonade Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2125-2014·2014-07-16

    Caramel Apple Swirl Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Caramel Apple Swirl Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Caramel Apple Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2105-2014·2014-07-16

    The Doctor's Cure Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling The Doctor's Cure Ice Cream because bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    The Doctor's Cure Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2153-2014·2014-07-16

    Dulce de Leche Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Dulce de Leche de Salte Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2087-2014·2014-07-16

    Mountain House Scrambled Eggs Recalled for Undeclared Allergens

    Oregon Freeze Dry is recalling Mountain House Scrambled Eggs with Ham and Peppers due to undeclared wheat, soy, and coconut, and potential mislabeling as Granola.

    Product
    Mountain House Freeze-Dried Precooked Scrambled Eggs with Ham and Red & Green Peppers, 19.4 oz 1 LB 3.4 oz), packed in #10 metal can. Product is labeled in part "***INGREDIENTS: Precooked Scrambled Eggs* (whole eggs, egg yolk, nonfat dry milk, modified corn starch, corn oil…
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-2151-2014·2014-07-16

    Policeman's Special Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling 7 units of Policeman's Special Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Policeman's Special Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2128-2014·2014-07-16

    Chocolate Bourbon Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Chocolate Bourbon Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Chocolate Bourbon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2095-2014·2014-07-16

    Peanut Butter Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Peanut Butter Cow Tracks Ice Cream because bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Peanut Butter Cow Tracks Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2093-2014·2014-07-16

    Cinnamon Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Cinnamon Ice Cream because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Cinnamon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2160-2014·2014-07-16

    Shirley's Red Velvet Cake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Shirley's Red Velvet Cake with White Chocolate Icing Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Shirley's Red Velvet Cake with White Chocolate Icing Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2169-2014·2014-07-16

    German Chocolate Cake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling German Chocolate Cake Ice Cream because bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Ze German Chocolate Cake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2161-2014·2014-07-16

    Green Tea Ice Cream Recalled for Missing Allergen Labeling

    Koogee-Queen Anne, LLC is recalling Green Tea Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Green Tea Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1998-2014·2014-07-16

    Mizuho Disposable Doppler Probe Recalled for Sterile Barrier Penetration

    Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.

    Product
    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2035-2014·2014-07-16

    Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.

    Product
    Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2124-2014·2014-07-16

    Candy Cane Lane Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Candy Cane Lane Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Candy Cane Lane Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2142-2014·2014-07-16

    Pretzel Logic Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Pretzel Logic Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Pretzel Logic Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2114-2014·2014-07-16

    Sorghum & Grits Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Sorghum & Grits Ice Cream because the product lacked required ingredient and allergen labels, including facility processing warnings.

    Product
    Sorghum & Grits Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2039-2014·2014-07-16

    Karl Storz Recalls Essential NEO Audio/Visual Units Due to Overheating Cable

    Karl Storz Endoscopy is recalling 968 Essential NEO audio/visual integration units because the connected power cable could overheat, generate smoke, and cause the peripheral to stop working.

    Product
    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2154-2014·2014-07-16

    Tiramisu Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Tiramisu Ice Cream because bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Tiramisu Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1995-2014·2014-07-16

    Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect

    Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.

    Product
    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2014·2014-07-16

    FDA Recalls Devon Surgical Positioning Kits Due to Strap Separation Risk

    The FDA is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits because straps may separate from the foam pad.

    Product
    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2112-2014·2014-07-16

    Old 502 Sangria Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Old 502 Sangria Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Old 502 Sangria Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2096-2014·2014-07-16

    Erica's PB&J Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Erica's PB&J Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Erica's PB&J Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2020-2014·2014-07-16

    Intuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk

    Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.

    Product
    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2137-2014·2014-07-16

    Jack and Cola Float Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Jack and Cola Float Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Jack and Cola Float Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2148-2014·2014-07-16

    Watermelon Mint Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Watermelon Mint Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Watermelon Mint Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2168-2014·2014-07-16

    Sister Bean's White Chocolate Mocha Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Sister Bean's White Chocolate Mocha Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Sister Bean's White Chocolate Mocha Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2146-2014·2014-07-16

    Shorty's Strawberry Shortcake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Shorty's Strawberry Shortcake Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Shorty's Strawberry Shortcake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2033-2014·2014-07-16

    Zimmer M/L Taper Hip Stem Recall Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.

    Product
    Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2157-2014·2014-07-16

    Shirley's Red Velvet Cake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2108-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Georgia Butter Pecan and Simply Southern Ice Cream because bulk products lacked required ingredient and allergen labels.

    Product
    Georgia Butter Pecan Ice Cream and Simply Southern Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2164-2014·2014-07-16

    Chocolate Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling chocolate ice cream because bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Chocolate "Chip Off the Old Block" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2133-2014·2014-07-16

    Fudgesicle Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Fudgesicle Sorbet because bulk products lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Fudgesicle Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2040-2014·2014-07-16

    Codan Recalls ColorSafe IV Lines Manufactured Before FDA Approval

    Codan US Corporation is recalling ColorSafe IV lines because they were manufactured and marketed prior to FDA approval.

    Product
    ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809)…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2083-2014·2014-07-16

    Cookies Cottage Crispy Taro Cookies Recalled for Undeclared Dyes

    U-Can Food Trading Inc. is recalling Crispy Taro Cookies due to undeclared dyes, including one not permitted for use.

    Product
    The Cookies Cottage (Brand) Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits), 180g. Packaged in 24packets per carton.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2032-2014·2014-07-16

    Zimmer EDI Periarticular Plating System Screws Recalled for Lot Commingling

    Zimmer Manufacturing B.V. is recalling 496 bone screws because two lots were commingled and packaged with incorrect labels.

    Product
    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2014·2014-07-16

    Teleflex Aquapak 340 SW Respiratory Gas Humidifier Adaptor Packaging Recall

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2090-2014·2014-07-16

    Hula Brand Hana Ebi Green Shrimp Flakes Recalled for Sulfites

    Modern Macaroni Co. is recalling Hula Brand Hana Ebi Green shrimp flakes because FDA testing found sulfites in the product.

    Product
    Hula Brand Products; Hana Ebi Green, artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages. Serving size 2 pinches (1 g) Manufactured by Modern Macaroni Co., Honolulu, HI Serving size is "2" pinches
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2010-2014·2014-07-16

    Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues

    Teleflex Medical is recalling Aqua 540 SW and 540 w/040 Adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

    Product
    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2088-2014·2014-07-16

    Coca-Cola Vanilla Recall Issued for Undeclared Aspartame Content

    The Coca-Cola Company is recalling specific lots of Coca-Cola Vanilla due to undeclared aspartame. Consumers should check their cans for the specific date code.

    Product
    Coca Cola Vanilla, 12 pack/12 fl oz cans, UPC: 49000 03124, Canned under authority of the Coca Cola Company, Atlanta, GA 30313 By a member of the Coca Cola Bottlers Association, Atlanta, GA.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2031-2014·2014-07-16

    Hospira Recalls GemStar Infusion Pumps Due to Beeper Connection Failure

    Hospira is recalling 36,881 GemStar infusion pumps because the beeper subassembly connection may fail, rendering the device inoperable.

    Product
    GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1430-2014·2014-07-16

    Teva Recalls Fluvastatin Capsules Due to Reported Capsule Breakage

    Teva Pharmaceuticals is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg, due to a customer complaint trend regarding capsule breakage.

    Product
    FLUVASTATIN — FLUVASTATIN (FLUVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2089-2014·2014-07-16

    Hana Ebi Red Shrimp Flakes Recalled for Sulfite Contamination

    Modern Macaroni Co. is recalling Hana Ebi Red shrimp flakes due to high sulfite levels found by the FDA.

    Product
    Hula Brand Products; Hana Ebi Red; artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages. Servins size 2 pinches (1 g) Manufactured by Modern Macaroni Co., Honolulu, HI Serving size is "2" pinches
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1422-2014·2014-07-16

    Healix Recalls Bupivacaine HCl Bags Due to Particulate Matter

    Healix Infusion Therapy is recalling 10 bags of BUPivacaine HCl 0.25% in On-Q C-bloc bags distributed in Texas due to visible particles.

    Product
    BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2012-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2014·2014-07-16

    Amerigel Wound Dressing Recalled for Manufacturing Process Concerns

    Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol and CGMP.

    Product
    Amerigel Wound Dressing 1 oz. tube
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1423-2014·2014-07-16

    United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect

    United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.

    Product
    Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2016-2014·2014-07-16

    Teleflex Medical Recalls Humidifier Adaptor 040 Due to Packaging Seal Issues

    Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.

    Product
    Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2014·2014-07-16

    Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues

    Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy in specific instructions.

    Product
    Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2024-2014·2014-07-16

    Aesculap Recalls Non-Sterile Sutures With Conflicting Sterile Labeling

    Aesculap is recalling 11 units of non-sterile Dafilon sutures because an additional label incorrectly states the product is sterile.

    Product
    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2011-2014·2014-07-16

    Teleflex Aquapak SW/EAU Sterile Respiratory Gas Humidifier Adaptor Packaging Recall

    Teleflex Medical is recalling Aquapak SW/EAU Sterile respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2014·2014-07-16

    Philips Gemini TF PET/CT Systems Recalled for E-Stop Malfunction

    Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.

    Product
    GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2005-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 101 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 101 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

    Product
    Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2014·2014-07-16

    Teleflex Medical Recalls Humidifier Adaptors Due to Packaging Seal Issues

    Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were distributed in the US and 12 other countries.

    Product
    Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2091-2014·2014-07-16

    Oaxaca Anelina Recalled for Undeclared and Unapproved Colors

    Oaxaca Mexican Products is recalling Anelina in 1/2 oz plastic bags because the product contains undeclared and unapproved colors.

    Product
    Oaxaca brand of Anelina in 1/2 oz plastic bags with paper label reading in part: "Oaxaca Mexican Products 100 8th Street Passaic New Jersey 07055 UPC 807310007466 ***"
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-1426-2014·2014-07-16

    Ferring Recalls Endometrin Vaginal Inserts Due to Discoloration

    Ferring Pharmaceuticals is recalling 72,046 cartons of Endometrin vaginal inserts nationwide due to discoloration caused by heat exposure.

    Product
    ENDOMETRIN — ENDOMETRIN (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2009-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2007-2014·2014-07-16

    Teleflex Medical Recalls Aquapak SW/EAU Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2013-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.

    Product
    Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2036-2014·2014-07-16

    Steris Recalls Reliance 1227 Washer Due to Door Handle Pin Deformation

    Steris is recalling 37 Reliance 1227 Cart and Utensil Washer/Disinfector units because the door handle pin may deform or break, potentially rendering the door inoperable.

    Product
    Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2018-2014·2014-07-16

    Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues

    Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.

    Product
    Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2015-2014·2014-07-16

    Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues

    Teleflex Medical is recalling 7,758,650 respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.

    Product
    Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2004-2014·2014-07-16

    Teleflex Medical Recalls Aquapak Respiratory Gas Humidifier Adaptors for Packaging Defects

    Teleflex Medical is recalling Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2006-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.