December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical: 72
Severe: 272
High: 309
Moderate: 311
Low: 64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

Which agencies issued them

601–700 of 1028

LowFDA (Devices)·Z-0544-2015·2014-12-17
Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance
Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does not meet FDA requirements for Pre-Amendment devices.
Product
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·14V796000·2014-12-16
Chrysler Recalls 2005 Dodge Ram 1500 Trucks for Rear Axle Defect
Chrysler is recalling 2005 Dodge Ram 1500 trucks because a rear axle pinion nut may loosen, potentially causing loss of vehicle control.
Product
DODGE — DODGE RAM 1500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V793000·2014-12-16
Terex Advance Recalls 2013-2015 Concrete Mixer Trucks for Suspension Defect
Terex Advance is recalling 2013-2015 Front Discharge Concrete Mixer Trucks because improperly secured nuts may cause the front axle leaf spring to partially disconnect, increasing crash risk.
Product
TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V795000·2014-12-16
Chrysler Recalls 2006-2007 Dodge and Mitsubishi Trucks for Ignition Switch Defect
Chrysler is recalling 54,164 vehicles because broken springs in the clutch ignition interlock switch can cause unintended movement or no-start conditions.
Product
DODGE — DODGE, MITSUBISHI RAM 2500, DAKOTA, RAM 3500, RAIDER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V794000·2014-12-16
Harley-Davidson Recalls 2012 Dyna and Softail Motorcycles for Brake Master Cylinder Defect
Harley-Davidson is recalling 19,015 model year 2012 Dyna and Softail motorcycles because corrosion in the front brake master cylinder could cause a loss of front brakes and increase crash risk.
Product
HARLEY-DAVIDSON — HARLEY-DAVIDSON SOFTAIL, DYNA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15047·2014-12-16
WindowTex Recalls Custom Roller Shades Due to Falling Hazard
WindowTex is recalling about 6,800 custom roller shades because a steel pin can dislodge, causing the shade to fall and pose an injury risk.
Product
Roller Window Shades
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·14V792000·2014-12-16
Honda Recalls Acura RLX Vehicles for Headlight Film Defect
Honda is recalling specific 2014-2015 Acura RLX and RLX Hybrid vehicles because headlight film may delaminate, reducing light output and increasing crash risk.
Product
ACURA — ACURA RLX, RLX HYBRID
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V791000·2014-12-15
Hino Recalls 2005-2015 Trucks Due to Parking Brake Wear
Hino is recalling 2005-2015 NE8J, NF8J, and ND8J trucks because parking brake components may wear, causing the brake to release or fail to engage, increasing crash risk.
Product
HINO — HINO NE8J, NF8J, ND8J
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14V790000·2014-12-15
Volkswagen Recalls 2015 Jetta Vehicles for Headlight Software Defect
Volkswagen is recalling 2015 Jetta vehicles because a software error may cause low beam headlights to turn off when high beams are activated, reducing visibility.
Product
VOLKSWAGEN — VOLKSWAGEN JETTA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14V789000·2014-12-15
MINI Cooper Recall for Transmission Software Rollaway Risk
BMW is recalling 2014-2015 MINI Cooper vehicles because incorrect transmission software may allow the car to roll away if the driver exits without engaging Park.
Product
MINI — MINI COOPER S, COOPER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14V788000·2014-12-15
Honda Recalls 2015 Crosstour Vehicles for Side Air Bag Defect
Honda is recalling 2015 Crosstour vehicles because the side curtain air bag inflator tube may be incorrectly manufactured, potentially affecting air bag performance in a crash.
Product
HONDA — HONDA CROSSTOUR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V787000·2014-12-12
Ford Recalls 2005-2006 GT Vehicles for Air Bag Inflator Defect
Ford is recalling 2005-2006 GT vehicles sold in high-humidity areas because the passenger air bag inflator may rupture during deployment, potentially causing serious injury.
Product
FORD — FORD GT
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15045·2014-12-12
UVEX Recalls Bicycle Helmets Due to Chinstrap Anchor Failure Risk
UVEX Sports is recalling 46,800 bicycle helmets because the chinstrap anchor can fail, causing the helmet to slide off and posing a head injury hazard.
Product
UVEX Bicycle Helmets
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0607-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Products Due to Listeria
Oasis Brands, Inc. is voluntarily recalling Lacteos Santa Martha brand products because Listeria monocytogenes was detected in related products and environmental samples.
Product
HonduCrema (Hunduran Olanchana Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha HonduCrema Crema Olanchana Olanchana Style Soft Blend Dairy Spread Net WT 1 LB (16 oz)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0595-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cheese Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha Queso Seco Centroamericano because Listeria monocytogenes was found in related products and environmental samples.
Product
Queso Seco Centroamericano (Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Centroamericano Dry White Cheese Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-0456-2015·2014-12-10
ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0601-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cheese for Listeria Contamination
Oasis Brands is voluntarily recalling Lacteos Santa Martha brand cheese products after Listeria monocytogenes was detected in samples.
Product
Queso Para Freir (Cheese for Frying) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso para Freir Cheese for Frying Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0605-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Products Due to Listeria
Oasis Brands is voluntarily recalling all Lacteos Santa Martha brand products within expiration date after Listeria monocytogenes was detected in environmental and product samples.
Product
Mantequilla Hondurena (Honduran Style Butter Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Mantequilla Hondurena Honduran Style Cream Net WT 1 LB (16 oz)
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-0459-2015·2014-12-10
ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0458-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Failure Risk
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0600-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cheese Due to Listeria
Oasis Brands, Inc. is voluntarily recalling Lacteos Santa Martha brand cheese products after Listeria monocytogenes was detected in environmental and product samples.
Product
Queso Cuzcatlan (Salvadorean Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Cuzcatlan Salvadorean Flavor Cheese Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-0383-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0454-2015·2014-12-10
ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure
ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposab
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0455-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0461-2015·2014-12-10
ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws
ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.
Product
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposa
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0462-2015·2014-12-10
ConMed Multifunction Electrodes Recalled for Connection Design Failure
ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.
Product
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0296-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.
Product
Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Food)·F-0598-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Fresh Curd Cheese Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha Quesito Casero Fresh Curd Cheese after Listeria monocytogenes was detected in the product and facility environmental samples.
Product
Quesito Casero (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Quesito Casero Fresh Curd Net Wt 12oz. (340g)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0609-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cream Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha Crema GuateLinda because Listeria monocytogenes was found in related products and environmental samples.
Product
Crema GuateLinda (Guatemalan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema GuateLinda Guatemalan Style Cream Net WT 1 LB (16 oz)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0596-2015·2014-12-10
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 environmental and product samples.
Product
Queso Seco Olanchano (Olanchano Style Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Olanchano Dry Cheese Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0599-2015·2014-12-10
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
My Queso (Latin Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha My Queso Latin Flavor Cheese Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0604-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Dairy Products for Listeria
Oasis Brands, Inc. is voluntarily recalling Lacteos Santa Martha dairy products after Listeria monocytogenes was detected in environmental and product samples.
Product
Crema Centroamericana (Centroamerican Style Soft Blend Dairy Spread) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Centroamericana Net Wt 1LB (16oz)
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-0311-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0460-2015·2014-12-10
ConMed Pediatric Electrodes Recalled Due to Connection Design Changes
ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.
Product
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0457-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0608-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cream Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha cream products after Listeria monocytogenes was detected in related products and environmental samples.
Product
Crema Guatemalteca (Guatemaltecan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Guatemalteca Guatemalan Style Cream Net WT 1 LB (16 oz)
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-0303-2015·2014-12-10
Customed Femoral Pack Recall Due to Compromised Sterility
Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Product
Femoral Pack, Catalog number 900-164. 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-0342-2015·2014-12-10
Customed Cystoscopy Pack III Recalled for Sterility Compromise
Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereNHTSA·14V785000·2014-12-10
Tishomingo Recalls 2012-2015 Quarter Frame Dump Trailers Due to Draft Arm Crack
Tishomingo is recalling 2012-2015 Quarter Frame dump trailers because the draft arm may crack or break, potentially causing loss of vehicle control.
Product
TISHOMINGO — TISHOMINGO QUARTER FRAME
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0354-2015·2014-12-10
Customed Extremity PACK Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 168 Extremity PACKs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Extremity PACK, catalog #900-2615 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-0257-2015·2014-12-10
Customed Mayo Stand Covers Recalled for Compromised Sterility
Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. 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-0373-2015·2014-12-10
Customed Laparoscopy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparoscopy Pack, Catalog number 900-3178. 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-0309-2015·2014-12-10
Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 120 OB Packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
OB Pack, Catalog number 900-1717. 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-0410-2015·2014-12-10
Customed Recalls Cataract Packs Due to Sterility Compromise
Customed, Inc. is recalling 1,140 cataract packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Cataract Pack, Catalog # 900-944 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-0240-2015·2014-12-10
Customed Wound Closure Tray I Recalled Due to Compromised Sterility
Customed, Inc. is recalling Wound Closure Tray I units because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Product
Wound Closure Tray I, Catalog number 900-063. 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-0326-2015·2014-12-10
Customed Angiography Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 212 Angiography Packs (Catalog 900-2038) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Angiography Pack, Catalog number 900-2038. 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 (Devices)·Z-0344-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 400 units of Laparotomy Pack 1 (2 & 3) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparotomy Pack 1 (2 & 3), catalog #900-2490 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-0368-2015·2014-12-10
Customed Hair Restoration Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 60 Hair Restoration Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Hair Restoration Pack, Catalog #900-2966 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-0357-2015·2014-12-10
Customed Liposuction Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Product
Liposuction Pack, catalog #900-2656 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-0366-2015·2014-12-10
Customed ACDF Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling six ACDF Packs (catalog #900-2917) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
ACDF Pack, catalog #900-2917 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-0246-2015·2014-12-10
Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling specific lots of Surgeon Gown Poly Reinforced Lgc because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Product
Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. 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-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-0356-2015·2014-12-10
Customed Open Heart Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 106 Open Heart Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Open Heart Pack, catalog #900-2618 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-0277-2015·2014-12-10
Customed Foley Catheter Kit Recalled Due to Compromised Sterility
Customed, Inc. is recalling 1,500 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Foley Catheter Kit, Catalog number 900-1139 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-0256-2015·2014-12-10
Customed Minor Laceration Trays Recalled Due to Compromised Sterility
Customed, Inc. is recalling Minor Laceration Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Minor Laceration Tray, Catalog number 900-1765. 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-0371-2015·2014-12-10
Customed Breast Packs Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 36 breast packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Breast Pack 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-0284-2015·2014-12-10
Customed Premium Laparotomy Pack Recalled for Compromised Sterility
Customed, Inc. is recalling Premium Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Premium Laparotomy Pack, Catalog number 900-1296. 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-0610-2015·2014-12-10
Oasis Brands Recalls Lacteos Santa Martha Cream Due to Listeria
Oasis Brands is voluntarily recalling Lacteos Santa Martha cream products after Listeria monocytogenes was detected in related products and environmental samples.
Product
Crema Cuzcatlan (Salvadorean Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Cuzcatlan Salvadorean Style Cream Net WT 1 LB (16 oz)
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-0369-2015·2014-12-10
Customed Tummy Tuck Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 18 Tummy Tuck Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Tummy Tuck Pack, Catalog #900-3026 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-0392-2015·2014-12-10
Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 340 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Arthroscopy Pack, Catalog number 900-620. 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-0269-2015·2014-12-10
Customed Cysto Tur Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 380 Cysto Tur Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Cysto Tur Pack, Catalog number 900-080. 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-0396-2015·2014-12-10
Customed O.B. Pack Recall Due to Sterility Compromise
Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
O.B. Pack, Catalog number 900-645. 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-0291-2015·2014-12-10
Customed Cardiovascular Case Cart Recalled for Compromised Sterility
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. 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-0262-2015·2014-12-10
Customed Gown Fabric Reinforced XXL Recalled for Compromised Sterility
Customed, Inc. is recalling 1,120 units of Gown Fabric Reinforced XXL due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Gown Fabric Reinforced XXL, Catalog number 900-2567. 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-0280-2015·2014-12-10
Customed Laparoscopy OB GYN Packs Recalled for Compromised Sterility
Customed, Inc. is recalling 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparoscopy OB GYN Pack, Catalog number 900-1192. 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-0267-2015·2014-12-10
Customed Laparoscopy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 1,152 Laparoscopy Packs (Catalog 900-028) because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Laparoscopy Pack, Catalog number 900-028. 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-0312-2015·2014-12-10
Customed Urology Pack Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in patient infection.
Product
Urology Pack, Catalog number 900-1738. 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-0388-2015·2014-12-10
Customed Recalls Pery GYN Surgical Packs Due to Sterility Compromise
Customed, Inc. is recalling 354 Pery GYN Surgical Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Pery GYN Surgical Pack, Catalog number 900-548A. 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-0315-2015·2014-12-10
Customed Ophthalmic Packs Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 582 Ophthalmic Packs due to compromised sterility and inadequate storage conditions that may result in patient infection.
Product
Ophtalmic Pack, Catalog number 900-1780. 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-0276-2015·2014-12-10
Customed Foley Catheter Kit Recalled for Compromised Sterility
Customed, Inc. is recalling 9,770 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Foley Catheter Kit, Catalog number 900-1127. 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-0395-2015·2014-12-10
Customed Recalls Pery Gyn Packs Due to Sterility Compromise
Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.
Product
Pery Gyn Pack, Catalog number 900-635. 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-0275-2015·2014-12-10
Customed Recalls Peri Gyn Packs Due to Compromised Sterility
Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Product
Peri Gyn Pack, Catalog number 900-1091. 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-0329-2015·2014-12-10
Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Femoral Pack, catalog #900-2164 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-0332-2015·2014-12-10
Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 880 surgical packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Product
Surgical Pack, catalog #900-2224 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-0337-2015·2014-12-10
Customed Vaginal Procedure Packs Recalled for Sterility Compromise
Customed, Inc. is recalling Vaginal Procedure Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Vaginal Procedure Pack, catalog #900-2385 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-0298-2015·2014-12-10
Customed Cardiovascular Case Carts Recalled for Compromised Sterility
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Cirugia Cardiovascular Case Cart, Catalog number 900-1500. 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-0355-2015·2014-12-10
Customed Shoulder Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 96 Shoulder Packs (catalog #900-2616) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Shoulder Pack, catalog #900-2616 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-0411-2015·2014-12-10
Customed Strabismus And Plastic Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Strabismus And Plastic Pack, Catalog # 900-946 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-0335-2015·2014-12-10
Customed Laparoscopy Colorectal Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparoscopy Colorectal Surgical Pack, catalog #900-2259A 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 (Devices)·Z-0237-2015·2014-12-10
Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Surgical packs (includes trays, bags and kits) 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-0352-2015·2014-12-10
Customed Arthroscopy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Arthroscopy Pack, catalog #900-2609 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-0330-2015·2014-12-10
Customed Lithotomy Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 460 Lithotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Lithotomy Pack, catalog #900-2167 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-0389-2015·2014-12-10
Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. 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-0317-2015·2014-12-10
Customed Arthroscopy Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 12 Arthroscopy Packs (Catalog 900-1832) because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Arthroscopy Pack, Catalog number 900-1832. 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-0412-2015·2014-12-10
Customed Arthoscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Arthoscopy Pack, Catalog # 900-982 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-0322-2015·2014-12-10
Customed Medical Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 160 Higado & Pancrea Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Higado & Pancrea Pack, Catalog number 900-1966. 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-0287-2015·2014-12-10
Customed Pediatric Lap Pack Recalled for Compromised Sterility
Customed, Inc. is recalling 56 Pediatric Lap Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Pediatric Lap Pack, Catalog number 900-1383 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-0384-2015·2014-12-10
Customed Laparoscopy Packs Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparoscopy Pack, Catalog number 900-474. 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-0313-2015·2014-12-10
Customed Urology Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 60 Urology Packs (Catalog 900-1742) because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Urology Pack, Catalog number 900-1742. 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-0381-2015·2014-12-10
Customed Labor and Delivery Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Labor & Delivery Pack, Catalog number 900-419. 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-0278-2015·2014-12-10
Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 132 Neuro Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Neuro Pack, Catalog number 900-1146. 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-0281-2015·2014-12-10
Customed Open Heart Tray Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Open Heart Tray, Catalog number 900-1196C 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-0367-2015·2014-12-10
Customed Recalls 51 TLIF Packs Due to Sterility and Contamination Risks
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Product
Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 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-0238-2015·2014-12-10
Customed Irrigation Tray Recall Due to Compromised Sterility
Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Irrigation Tray With Bulb Syringe, Catalog number 900-020. 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-0241-2015·2014-12-10
Customed Wound Closure Tray II Recalled for Compromised Sterility
Customed, Inc. is recalling Wound Closure Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states

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