Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

24276–24300 of 32189

SevereFDA (Devices)·Z-0290-2015·2014-12-10
Customed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility
Customed, Inc. is recalling 48 Umbilical Vessel Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0360-2015·2014-12-10
Customed Knee and Hip Replacement Trays Recalled for Sterility Compromise
Customed, Inc. is recalling 160 Knee and Hip Replacement trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0334-2015·2014-12-10
Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 114 Neuro Packs (catalog #900-2256) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0340-2015·2014-12-10
Customed Basic Pack 1 (III) Recalled for Sterility Compromise
Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0406-2015·2014-12-10
Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0365-2015·2014-12-10
Customed Cysto Tur Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 128 Cysto Tur Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Food)·F-0603-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Fresh Curd Cheese for Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha Fresh Curd Cheese after Listeria monocytogenes was detected in product and environmental samples.
Product
Cuajada en Hoja (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd Net Wt 12oz (340g)
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-0314-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.
Product
Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0258-2015·2014-12-10
Customed Wound Management Tray Recalled for Compromised Sterility
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0328-2015·2014-12-10
Customed Recalls Knee Arthroscopy Packs Due to Sterility Compromise
Customed, Inc. is recalling 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.
Product
Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0239-2015·2014-12-10
Customed Universal Drainage Tray Recalled Due to Compromised Sterility
Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0301-2015·2014-12-10
Customed Universal Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Product
Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0403-2015·2014-12-10
Customed Laparotomy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0292-2015·2014-12-10
Customed Recalls Reyito Urological Packs Due to Compromised Sterility
Customed, Inc. is recalling 315 Reyito Urological Packs because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Product
Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Food)·F-0597-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cheese Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha brand cheese products after Listeria monocytogenes was detected in samples.
Product
Queso Seco Hondureno (Honduran Style Dry Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Hondureno Dry Cheese Net Wt 12oz (340g)
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-0327-2015·2014-12-10
Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0272-2015·2014-12-10
Customed Laparoscopy Chole Pack Recalled for Compromised Sterility
Customed, Inc. is recalling 480 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0249-2015·2014-12-10
Customed Incision and Drainage Trays Recalled for Compromised Sterility
Customed, Inc. is recalling 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0336-2015·2014-12-10
Customed Full Body Drape Recalled for Sterility Compromise
Customed, Inc. is recalling 308 units of General Line Full Body Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0394-2015·2014-12-10
Customed Fanfold Drape Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 6,300 Fanfold Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0376-2015·2014-12-10
Customed Basic Pack W/Out Gown Recalled for Sterility Compromise
Customed, Inc. is recalling 242 units of Basic Pack W/Out Gown due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0333-2015·2014-12-10
Customed Ear Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 105 Ear Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0398-2015·2014-12-10
Customed Arthroscopy Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 400 Arthroscopy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0339-2015·2014-12-10
Customed Extremity Arm Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 92 Extremity Arm Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0264-2015·2014-12-10
Customed Surgical Gowns Recalled Due to Compromised Sterility
Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Product
Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states