Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

37701–37725 of 50506

HighFDA (Food)·F-3084-2015·2015-09-09
Westbrook's Cannery Hot Dill Pickles Recalled for Potential Underprocessing
Westbrook's Cannery is recalling 566 jars of Hot Dill Pickles because they may be underprocessed. The product was distributed to 11 states.
Product
WESTBROOK'S CANNERY HOT DILL PICKLES, Net WT. 16 oz (453.592g) glass jars, Ingredients: White Distilled Vinegar, Water, Cucumbers, Alum, Pickling Salt, Spices 206 Dueber Ave SW Canton, OH 44706 234-214-8215 www.wesbrookscannery.com UPC 8 53238 00404 9
Category
Food
Distribution
11 states
HighFDA (Food)·F-3085-2015·2015-09-09
Westbrook's Hot Dilly Beans Recalled for Potential Underprocessing
Westbrook's Cannery is recalling 12-ounce jars of Hot Dilly Beans because the product may be underprocessed. Consumers in 11 states should stop using the product.
Product
Westbrook's Hot Dilly Beans, Net WT. 12 oz (354.882G) glass jars, Ingredients: Green Beans, White Distilled Vinegar, Water, Pickling Salt, Jalapenos, Garlic Cloves, Dill Seed, Dill Weed, Alum www.wesbrookscannery.com 330-874-8120 UPC 8 53238 00439 1
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-2584-2015·2015-09-09
Customed Wound Management Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 580 wound management kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-2815-2015·2015-09-09
Christie Cookie Co Recalls Doubletree Cookie Dough Due to Plastic Contamination
Christie Cookie Co Inc is recalling Doubletree Cookie Dough because reports indicate the presence of clear and green plastic pieces in the cookies.
Product
Doubletree Cookie Dough, item number 2603450, Contents: 106 pieces, Net Weight: approx. 15 lbs. (6.8 kg), Mfg by: The Christie Cookie Co, Nashville, TN
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 180 packs of Arthroscopy PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2515-2015·2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2712-2015·2015-09-09
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 874 C-Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2567-2015·2015-09-09
Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 280 Foley Catheter Kits II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2711-2015·2015-09-09
Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 105 Plastic Surgery Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2636-2015·2015-09-09
Customed EENT Pack I Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling EENT Pack I sterile medical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EENT PACK I (1) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2631-2015·2015-09-09
Customed Central Line Full Body Drapes Recalled for Sterilization Issues
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes due to inadequate validation of sterilization processes and package integrity.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2557-2015·2015-09-09
Customed Wound Closure Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,350 Wound Closure Tray II units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2623-2015·2015-09-09
Customed Knee Arthroscopy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 188 Knee Arthroscopy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2530-2015·2015-09-09
Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 53 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2689-2015·2015-09-09
Customed Utility Drapes Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Utility Drapes due to inadequate validation of sterilization processes and package integrity.
Product
UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2677-2015·2015-09-09
Customed Labor and Delivery Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 300 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2595-2015·2015-09-09
Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 180 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2673-2015·2015-09-09
Customed Major Lap Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.
Product
MAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighCPSC·15239·2015-09-09
Cabrinha Recalls Kiteboard Control Systems Due to Trim Line Breakage Risk
Cabrinha is recalling specific kiteboard control systems because the trim line can break, causing loss of control and posing a risk of injury.
Product
Cabrinha Kiteboard control systems
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2495-2015·2015-09-09
Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling specific KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the device's intended function.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2015·2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,142 units of Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2619-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2620-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 3,000 units of gauze sponges due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2594-2015·2015-09-09
Customed Medical Leggings Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 300 units of medical leggings used for surgical and patient care procedures due to inadequate sterilization validation and package integrity issues.
Product
LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2680-2015·2015-09-09
Customed Laparoscopy Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 244 laparoscopy kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state