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.

37776–37800 of 50506

HighFDA (Devices)·Z-2694-2015·2015-09-09
Customed Recalls O.R. Towels Due to Sterilization Process Validation Issues
Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
O.R. TOWELS 25/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-2701-2015·2015-09-09
Customed Recalls Carpal Tunnel Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
CARPAL TUNEL LARGE SURGICAL 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-2646-2015·2015-09-09
Customed Inc Recalls Sterile Hip and Knee Replacement Surgical Kits
Customed, Inc. is recalling 39 sterile hip and knee replacement kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
HIP AND KNEE REPLACEMENT 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-2504-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
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, Elbow, D-Tip (Product Code 2219) 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-2613-2015·2015-09-09
Customed HIP Ortho. Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
HIP ORTHO. PACK 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-2607-2015·2015-09-09
Customed Urology PK 5/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PK 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-2505-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising the closed system.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2639-2015·2015-09-09
Customed Shoulder Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 12 units of Shoulder Packs (I) (2) due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER PACK (I) (2) 6/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-2565-2015·2015-09-09
Customed Tracheotomy Care Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 3,550 Tracheotomy Care Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
TRACHEOTOMY CARE KIT 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-2716-2015·2015-09-09
Customed PERI GYN PACK recalled for sterilization validation issues
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS due to inadequate validation of sterilization processes and package integrity.
Product
PERI GYN 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-2606-2015·2015-09-09
Customed Minor Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 945 Minor Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
MINOR LAP. PACK 5/CS REV. 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-2661-2015·2015-09-09
Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling obstetrical surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OBSTETRICAL SURGICAL 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-2554-2015·2015-09-09
Customed Major Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,084 packs of Major Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
Product
MAJOR LAPAROTOMY 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-2605-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 104 units of Cesarean Packs 4/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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-2550-2015·2015-09-09
Customed O.B. PK Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 48 packs of O.B. PK surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. 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-2653-2015·2015-09-09
Customed Medical Device Recall for Sterilization Validation Deficiencies
Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
REEMPLAZO DE RODILLA Y CADERA 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-2575-2015·2015-09-09
Customed Premium Cesarean Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 Premium Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM CESAREAN 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-2600-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 96 units of Cesarean Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PACK 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-2612-2015·2015-09-09
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 546 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OPHTHALMIC 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-2657-2015·2015-09-09
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,866 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY SURGICAL PACK 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-2500-2015·2015-09-09
Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Product
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2015·2015-09-09
Customed Recalls Sterile Surgical Kits Due to Sterilization Validation Issues
Customed, Inc. is recalling 248 units of sterile surgical kits in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
HIGADO Y PANCREA 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-2528-2015·2015-09-09
Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.
Product
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2531-2015·2015-09-09
Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.
Product
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2514-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Turbo-Cleaning Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the…
Category
Medical Device
Distribution
Distributed nationwide