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.

36101–36125 of 50504

HighFDA (Devices)·Z-1437-2016·2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE 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-1462-2016·2016-04-20
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 85 orthopedic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK 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-1387-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks
Synthes (USA) Products LLC is recalling 317 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2016·2016-04-20
Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 96 Cesarean Section Surgical Packs due to inadequate sterilization validation and package integrity issues.
Product
Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK 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-1476-2016·2016-04-20
Customed Wound Management Tray III Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900540 WOUND MANAGEMENT TRAY III 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-1484-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 108 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK 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·16149·2016-04-20
YTL International Recalls Drywall Lifts Due to Injury Hazard
YTL International is recalling about 17,000 drywall lifts because they can fail and drop loads, posing an injury risk. No injuries have been reported.
Product
Drywall lifts
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2016·2016-04-20
Arjo Concerto Basic Shower Trolley Recalled for Loose Bolts
Arjo is recalling 1,596 Concerto Basic Shower Trolleys because bolts connecting the stretcher to the hydraulic piston and tilting mechanism may become loose.
Product
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is…
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1486-2016·2016-04-20
Customed Carpal Tunnel Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 162 carpal tunnel surgical packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK 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-1074-2016·2016-04-20
Hidden Valley Original Ranch Dressing Recalled for Missing Soy Label
The Clorox Company is recalling Hidden Valley Original Ranch dressing because some bottles are missing the soy lecithin ingredient declaration.
Product
Hidden Valley Original Ranch dressing, 16 fl oz. ( 473 ml). plastic bottles; Ingredients: Vegetable oil (soybean and/or Canola oil) water, egg yolk, sugar, Salt, Cultured non fat buttermilk, natural flavors (milk, soy), less than 1% spiced, dried garlic, dried onion, vinegar…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2016·2016-04-20
Customed Laparoscopic Gynecology Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Product
Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK 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-1380-2016·2016-04-20
Philips EPIQ Ultrasound Systems Recalled for Control Panel Fastener Loosening
Philips is recalling EPIQ diagnostic ultrasound systems because fasteners securing the control panel may loosen, potentially causing the assembly to detach.
Product
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1373-2016·2016-04-20
Maquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk
Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.
Product
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2016·2016-04-20
Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 380 units of Foley Catheter Trays in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY 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-1418-2016·2016-04-20
Customed Premium Laparotomy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 258 Premium Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK 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-1471-2016·2016-04-20
Customed Laparoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 120 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK 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-1061-2016·2016-04-20
Stratas Foods Recalls Canola Salad Oil Due to Potential Plastic Contamination
Stratas Foods is recalling 218 cases of Silver Source Canola Salad Oil because a supplier reported that pieces of plastic from container necks may be present in the product.
Product
Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 42770 7
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1495-2016·2016-04-20
Customed PERI-GYN Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of PERI-GYN Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900997 PERI-GYN SURGICAL PACK 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-1463-2016·2016-04-20
Customed Cysto TUR Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002899 CYSTO TUR SURGICAL PACK 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-1397-2016·2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because the company could not validate the sterilization process or package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE 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-1376-2016·2016-04-20
Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.
Product
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2016·2016-04-20
Customed Basic Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900345 BASIC SURGICAL PACK 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-1489-2016·2016-04-20
Customed Femoral Angiography Surgical Pack Recalled for Sterilization Issues
Customed, Inc. is recalling 16 units of Femoral Angiography Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK 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-1423-2016·2016-04-20
Customed Recalls Umbilical Vessel Catheter Kits Due to Sterilization Concerns
Customed, Inc. is recalling 40 umbilical vessel catheter kits distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT 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
HighNHTSA·16V223000·2016-04-19
New Flyer Transit Buses Recalled for Rear Door Software Defect
New Flyer is recalling specific transit buses because a software defect may cause the rear door to open unexpectedly while the bus is moving, increasing injury risk.
Product
NEW FLYER — NEW FLYER XN40, XN60, C40LFR, XN35
Category
Vehicle
Distribution
Distributed nationwide