February 2021 recalls

492 recalls were announced in February 2021.

What the numbers show

Critical: 13
Severe: 87
High: 329
Moderate: 56
Low: 7

Of the 492 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

Which agencies issued them

201–300 of 492

HighFDA (Devices)·Z-1088-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.
Product
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V080000·2021-02-17
2021-2022 Kenworth and Peterbilt trucks recalled for improperly torqued flywheel attachment
PACCAR is recalling certain 2021-2022 Kenworth and Peterbilt heavy trucks equipped with Cummins X15 engines. The flywheel attachment capscrews may be improperly torqued, risking flywheel detachment and loss of drive power.
Product
PETERBILT — PETERBILT, KENWORTH 389, 567, T800B, W900
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21080·2021-02-17
Toro Recalls Power Max Snowthrowers Due to Amputation Hazard
Toro is recalling about 6,700 Power Max 826 OHAE snowthrowers because the auger may fail to disengage, posing an amputation hazard.
Product
Toro Power Max Snowthrowers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·21081·2021-02-17
Jimco Recalls J Hunt Home Accent Tables Due to Shock Hazard
Jimco Lamp is recalling J Hunt Home accent tables with charging receptacles due to a shock hazard caused by reverse polarity. No injuries have been reported.
Product
J Hunt Home and J Hunt and Co. Accent Tables with Charging Receptacles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk.
Product
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V083000·2021-02-17
Blue Bird Recalls 2021-2022 School Buses Due to Electronic Stability Control Defect
Blue Bird is recalling 2021-2022 Vision and 2022 All American school buses because the hydraulic brake control unit may be programmed incorrectly, causing electronic stability control to malfunction.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V077000·2021-02-17
Mercedes-Benz Sprinter Recall for Rearview Camera Display Delay
Daimler Vans USA is recalling 2019-2020 Mercedes-Benz and Freightliner Sprinter vans because the rearview camera image may be delayed or obscured, increasing crash risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 4500, SPRINTER 2500, SPRINTER 3500, SPRINTER 1500
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, which could lead to patient infection.
Product
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2021·2021-02-17
Aomori Olympus Recalls ForceMax Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V079000·2021-02-17
International LoneStar and LT battery cable defect increases crash risk
Navistar is recalling certain 2017-2021 International LoneStar and LT vehicles because the battery ground cable may break, causing unintended engine shutdown and increasing the risk of a crash.
Product
INTERNATIONAL — INTERNATIONAL LONESTAR, LT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V084000·2021-02-17
Blue Bird Recalls 2022 All American Buses Due to Electronic Stability Control Defect
Blue Bird is recalling 2022 All American buses because a programming error in the hydraulic brake control unit may cause the electronic stability control to malfunction.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V078000·2021-02-17
2020-2021 Audi Q7 recalled for premature air bag deployment hazard
The air bag control module in certain 2020-2021 Audi Q7 vehicles may deploy the second stage of the front passenger air bag too quickly when an unbelted child is in the seat, increasing injury risk. Audi will update the module at no cost.
Product
AUDI — AUDI Q7
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Inadequate Package Seals
Aomori Olympus is recalling INJECTOR FORCEMAX LOWER 23G 4MM devices because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2021·2021-02-17
Aomori Olympus Recalls ForceMax UP Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1005-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Inadequate Package Seals
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages had inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2021·2021-02-17
Aomori Olympus Recalls K-203 Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1006-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1001-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2021·2021-02-17
Aomori Olympus Recalls MAJ-247 Replacement Baskets Due to Seal Defects
Aomori Olympus is recalling MAJ-247 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.
Product
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1103-2021·2021-02-17
DePuy Universal Femoral Sleeves Recalled for Taper Dimension Issues
DePuy Orthopaedics is recalling 60 Universal Femoral Sleeves because taper dimensions may be out of specification due to a manufacturing issue.
Product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1063-2021·2021-02-17
Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2021·2021-02-17
Aomori Olympus Recalls K-201 Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-201 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk if used.
Product
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2021·2021-02-17
Aomori Olympus Recalls B5-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2C balloon catheters because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling NA-401D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, creating a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2021·2021-02-17
Aomori Olympus Recalls B5-2Q Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2021·2021-02-17
Aomori Olympus Recalls B7-2Q Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2021·2021-02-17
Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2021·2021-02-17
Aomori Olympus Vizishot Aspiration Needle Recall for Package Seal Defects
Aomori Olympus is recalling Vizishot 22G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-15 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-25 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection.
Product
SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2021·2021-02-17
Aomori Olympus Recalls MAJ-244 Replacement Baskets Due to Seal Defects
Aomori Olympus is recalling MAJ-244 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.
Product
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2021·2021-02-17
Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, which could lead to infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21083·2021-02-17
Anker Play Recalls Science Kits Due to Lead Paint Violation
Anker Play Products is recalling 10-in-1 Incredible Inventions Science Kits because the red and blue magnet contains lead paint exceeding federal limits.
Product
10-in-1 Incredible Inventions Science Kits
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·21079·2021-02-17
Presto Recalls Indoor Electric Smokers Due to Electric Shock Hazard
National Presto is recalling about 25,000 Presto Indoor Electric Smokers because defective heating elements pose an electric shock hazard.
Product
Presto Indoor Electric Smoker
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·21082·2021-02-17
Primark Recalls Nose Piercings and Body Bars Due to Nickel Levels
Primark is recalling 5-pack nose piercings and body bars because they contain high levels of nickel, posing a risk of skin irritation.
Product
5-Pack Nose Piercings and Body Bars
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0992-2021·2021-02-17
Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects
Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2021·2021-02-17
Aomori Olympus Recalls ForceMax UP Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
Product
Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax Lower 23G 5MM injectors because some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2021·2021-02-17
Aomori Olympus Recalls KD-650U Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650U Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2021·2021-02-17
GE Healthcare Precision 600FP Monitor Suspension Recall
GE Healthcare is recalling 113 Precision 600FP systems due to a potential monitor suspension defect that could cause injury.
Product
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1008-2021·2021-02-17
Aomori Olympus Recalls ForceMax Injectors Due to Package Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-15 electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.
Product
SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1026-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0289-2021·2021-02-17
Publix Parmesan-Crusted Wild Alaskan Salmon Recalled for Undeclared Soy
Ocean Beauty Seafoods LLC is recalling 845 cases of Publix Parmesan-Crusted Wild Alaskan Salmon Fillets due to undeclared soy. The product was distributed in Florida and Georgia.
Product
The RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net wt. 12 oz. Each retail box has 2 individually vacuum-packaged portions of 5oz salmon with 1oz of glaze of soy sauce for each portion. The salmon
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1054-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-401D-1321 aspiration needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2021·2021-02-17
Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling ViziShot 22G aspiration needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2021·2021-02-17
Draegar Infinity Acute Care System Recall for Random Reboot Defect
Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.
Product
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster 3mm x 26G Lower needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0958-2021·2021-02-17
ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices are distributed worldwide and across multiple U.S. states.
Product
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the ad
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2021·2021-02-17
Aomori Olympus Recalls KD-650L Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650L Electrosurgical Snare units because some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2021·2021-02-17
BEMER Therapy Systems Recalled for Potential Interference with Pacemakers and Insulin Pumps
BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems because electromagnetic fields may cause technical defects in insulin pumps or pacemaker malfunctions.
Product
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1058-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-601D-1519 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate mate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-10 electrosurgical snares because inspection found inadequate package seals. Non-sterile equipment use may lead to patient infection.
Product
SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Inadequate Package Seals
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2021·2021-02-17
Aomori Olympus Recalls Needlemaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling Needlemaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-411D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2021·2021-02-17
Aomori Olympus NeedleMaster Endoscopic Injection Needles Recalled for Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2021·2021-02-17
Arjo Flat Dynamic Positioning System Recalled for Sling Clip Breakage Risk
Arjohuntleigh Magog is recalling 3,390 Arjo Flat Dynamic Positioning Systems due to a risk of sling clip breakage during use.
Product
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceilin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling Vizishot 21G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2021·2021-02-17
ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.
Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1087-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
Product
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body flui
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1080-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1081-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1079-2021·2021-02-17
Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects
Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.
Product
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1096-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate ma
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0957-2021·2021-02-17
ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.
Product
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system throug
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1090-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material.
Product
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate mat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0276-2021·2021-02-17
Hiland Chocolate Milk Recalled for Food Grade Sanitizer Contamination
Hiland Dairy Foods is recalling 1% Lowfat Chocolate Milk contaminated with food grade sanitizer. The product was distributed in Oklahoma and Texas.
Product
HIland 1% Lowfat Chocolate Milk Half Pint UPC: 72060-00156-3 packaged in a paper carton 50 cartons per case
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1092-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
Product
Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate mat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1095-2021·2021-02-17
Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects
Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1106-2021·2021-02-17
Arrow AGB+ Multi-Lumen CVC Kit Recalled for Labeling Error
Arrow International Inc. is recalling 1,705 kits due to a potential product code mislabeling that could cause delays or allergic reactions in sensitive patients.
Product
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0280-2021·2021-02-17
Renaissance Food Group Recalls Buffalo Style Chicken Sliders Due to Labeling Error
Renaissance Food Group, LLC is recalling Buffalo Style Chicken Sliders because the product label incorrectly lists ingredients for a different item and omits soy.
Product
BUFFALO STYLE CHICKEN Sliders NET WT. 5OZ (141g) Ingredients: Tuna Salad*** CONTAINS: EGG, FISH (TUNA), MILK, WHEAT Distributed By Renaissance Food Group, LLC 4322 Moreland Ave. Conley, GA 30288 UPC 8 26766 15590 3
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1089-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
Product
Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate mater
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1094-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential defects like rips, holes, and foreign material.
Product
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate m
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats because they may have rips, holes, or open seams that compromise barrier protection.
Product
Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate m
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1099-2021·2021-02-17
Cytocell Recalls Aquarius CRLF2 Distal Probe Due to Faint Signal Risk
Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green because faint additional signals may cause normal samples to be misreported as abnormal.
Product
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1091-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential manufacturing defects such as rips, holes, and foreign material.
Product
Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate ma
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1083-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Chemo Prep and Admin Kits
Cardinal Health is recalling ChemoPlus Chemo Prep & Admin Kits because the included gowns may have defects like rips, holes, or foreign material.
Product
ChemoPlus" Chemo Prep & Admin Kit, CT4025
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1107-2021·2021-02-17
Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
Product
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1097-2021·2021-02-17
Cardinal Health Recalls Kendall Blue XXL Gowns Due to Defects
Cardinal Health is recalling Kendall Blue XXL gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1082-2021·2021-02-17
Cardinal Health Recalls Kendall Spill Kits Due to Gown Defects
Cardinal Health is recalling Kendall Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1078-2021·2021-02-17
Cardinal Health Recalls Chemo Spill Kits Due to Gown Defects
Cardinal Health is recalling 137,346 ChemoPlus Chemo Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Category
Medical Device
Distribution
Distributed nationwide

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