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.

37651–37675 of 50506

HighFDA (Devices)·Z-2508-2015·2015-09-09
Halyard KimVent Closed Suction System Recall for Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2015·2015-09-09
Volcano Pioneer Plus Re-Entry Catheter Recalled for Manufacturing Defect
Volcano Corporation is recalling 5,042 Pioneer Plus Re-Entry Catheters due to a manufacturing defect that may allow a small wire to extend through the catheter shaft.
Product
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2656-2015·2015-09-09
Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
URETHRAL CATHETER TRAY 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-2702-2015·2015-09-09
Customed Incision and Drainage Trays Recalled for Sterilization Defects
Customed, Inc. is recalling 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
INCISION AND DRAINAGE TRAY 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-2641-2015·2015-09-09
Customed O.B. Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 125 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK 5/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·15237·2015-09-09
Panasonic Recalls Metal Cutter Saws Due to Laceration Hazard
Panasonic is recalling specific cordless metal cutter saw kits because the lower blade guard can get stuck, exposing the blade and posing a laceration hazard.
Product
Metal Cutter Saw Kit and Metal Cutter Combo Kit
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2664-2015·2015-09-09
Customed Face Lift Medical Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 units of Face Lift medical kits due to inadequate validation of sterilization processes and package integrity.
Product
FACE LIFT 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-2662-2015·2015-09-09
Customed Hair Restoration Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 18 units of Hair Restoration Packs due to inadequate validation of sterilization processes and package integrity.
Product
HAIR RESTORATION PACK-THR 12/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-2629-2015·2015-09-09
Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
NEURO PACK 2/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-2551-2015·2015-09-09
Customed Irrigation Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 4,800 irrigation trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2502-2015·2015-09-09
Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising airway protection.
Product
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2587-2015·2015-09-09
Customed E.N.T. PK 7/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 63 units of E.N.T. PK 7/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
E.N.T. PK 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 (Food)·F-3080-2015·2015-09-09
Westbrook's Cannery Recalls Dill Pickles Due to Underprocessing Concerns
Westbrook's Cannery is recalling 16 oz glass jars of Dill Pickles because the products may be underprocessed. Consumers should check lot codes and stop using the product.
Product
WESTBROOK'S CANNERY DILL PICKLES, 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 00406 3
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-2577-2015·2015-09-09
Customed Premium O.B. Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 390 packs of Premium O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM O.B. PACK CUSTOMED 5/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-2578-2015·2015-09-09
Customed Premium Arthroscopy PK Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM ARTHROSCOPY PK CUSTOMED 5/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-2647-2015·2015-09-09
Customed Extremity Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 285 units of Extremity Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EXTREMITY 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
HighFDA (Devices)·Z-2561-2015·2015-09-09
Customed Laparoscopic Cholecystectomy Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 426 laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
LAPAROSC CHOLE 3/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-2570-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 138 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PACK 6/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-2617-2015·2015-09-09
Customed Shoulder Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER PACK CUSTOMED 3/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-2669-2015·2015-09-09
Customed Breast Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 33 units of Breast Pack-TPSC in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
BREAST PACK-TPSC 3/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-2644-2015·2015-09-09
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 216 units of Cool Impervious XLGE Breathable surgical gowns due to inadequate validation of sterilization processes and package integrity.
Product
GOWN COOL IMPEV. XLGE BREATHABLE 24/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-2519-2015·2015-09-09
Halyard KimVent Suction Catheter Thumb Valve Recall
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction system.
Product
KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2529-2015·2015-09-09
Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling specific Mahurkar Elite Acute Dual Lumen Catheter Trays because their sterility may be compromised.
Product
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 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-2674-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 490 Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PACK 2/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-2706-2015·2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 264 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK CS/6 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