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.

36051–36075 of 50504

HighFDA (Devices)·Z-1386-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal
Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures if a surgeon attempts to remove it.
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-1363-2016·2016-04-20
Natus Medical Recalls Medix NatalCare ST-LX Neonatal Incubators
Natus Medical is recalling Medix NatalCare ST-LX neonatal incubators because defective hinge assemblies may cause ports to detach.
Product
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2016·2016-04-20
Customed Recalls Sterile Surgical Towels Due to Sterilization Validation Issues
Customed, Inc. is recalling 125 sterile surgical towels distributed in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Product
Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE 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-1465-2016·2016-04-20
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL 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-1441-2016·2016-04-20
Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002123 KNEE 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
HighFDA (Food)·F-1060-2016·2016-04-20
Stratas Foods Recalls Silver Source Creamy Fry Oil Due to Plastic Contamination
Stratas Foods is recalling 840 cases of Silver Source Creamy Fry Oil because a supplier reported that a piece of plastic from a container neck finish may be present in the product.
Product
Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02236 0
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1455-2016·2016-04-20
Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002618 OPEN HEART 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-1384-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks
Synthes (USA) Products LLC is recalling 200 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-1467-2016·2016-04-20
Customed Cesarean Section Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 48 Cesarean Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900403 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-1445-2016·2016-04-20
Customed Surgical Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 280 surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002224 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-1447-2016·2016-04-20
Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 84 laparoscopy-colorectal surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL 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
HighNHTSA·16V229000·2016-04-20
Jaguar Recalls XF Vehicles Due to Driver Air Bag Defect
Jaguar is recalling certain 2009, 2011, 2012, and 2015 XF vehicles because the driver frontal air bag may deploy improperly, increasing injury risk.
Product
JAGUAR — JAGUAR XF
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2016·2016-04-20
Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 9,000 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900010 SUTURE REMOVAL 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
HighFDA (Devices)·Z-1426-2016·2016-04-20
Customed ENT Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 70 ENT Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001482 ENT 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-1490-2016·2016-04-20
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 238 C-Section Surgical Packs because the sterilization processes and package integrity were not adequately validated.
Product
Catalog Number: 900921A C-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-1414-2016·2016-04-20
Customed Wound Management Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,088 Wound Management Trays because sterilization processes and package integrity were not adequately validated.
Product
Catalog Number: 9001154 WOUND MANAGEMENT TRAY 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-1430-2016·2016-04-20
Customed Medical Leggings Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 270 units of medical leggings used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF 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-1435-2016·2016-04-20
Customed Laparotomy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 938 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900176 LAPAROTOMY 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-1444-2016·2016-04-20
Customed Shoulder Arthroscopy Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 42 shoulder arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002193 SHOULDER 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
HighFDA (Devices)·Z-1469-2016·2016-04-20
Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900419 LABOR & DELIVERY 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-1493-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900982 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
HighFDA (Devices)·Z-1450-2016·2016-04-20
Customed Minor Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002511 MINOR 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-1403-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 132 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900036 LAPAROTOMY 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-1488-2016·2016-04-20
Customed sterile skin staple remover recalled for sterilization validation issues
Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900782 SKIN STAPLE REMOVER 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-1454-2016·2016-04-20
Customed Extremity Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 136 Extremity Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002615 EXTREMITY 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