March 2021 recalls

387 recalls were announced in March 2021.

What the numbers show

Critical: 11
Severe: 150
High: 165
Moderate: 46
Low: 15

Of the 387 recalls this month scored against our rubric, 3% are Critical, 39% are Severe.

Which agencies issued them

1–100 of 387

CriticalFDA (Food)·F-0347-2021·2021-03-31
El Abuelito Quesillo Recalled for Listeria Monocytogenes Contamination
El Abuelito Cheese, Inc. is recalling multiple brands of Quesillo due to potential Listeria monocytogenes contamination. The product was distributed in six states.
Product
Quesillo sold under the following brands and container sizes: El Abuelito Cheese Quesillo Abuelito 12oz Vacuum Pack 673130200000 Quesillo Abuelito 5Lbs Vacuum Bag Loose Bag 673130500001 Quesillo Abuelito 10Lbs Vacuum Bag Loose Bag 673130600008 El Viejito El Viejito 10Lbs Vacuu
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0345-2021·2021-03-31
El Abuelito Queso Fresco Recalled for Listeria Contamination Risk
El Abuelito Cheese, Inc. is recalling various brands of Queso Fresco due to potential Listeria monocytogenes contamination. The product was distributed in six states.
Product
Quseo Fresco sold under the following brands and container sizes - El Abuelito Cheese Brand - Queso Fresco Regular 12 oz.Plastic Container673130100003 Queso Fresco Promoci¿n 10 oz.Plastic Container673130100078 Queso Fresco de Hoja 12 oz.Plastic Container673130100065 Qu
Category
Food
Distribution
6 states
CriticalFDA (Drugs)·D-0311-2021·2021-03-31
Adam's Secret Extra Strength 3000 Recalled for Unapproved Ingredients
The FDA is recalling Adam's Secret Extra Strength 3000 because it contains unapproved drugs tadalafil and sildenafil.
Product
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0348-2021·2021-03-31
Nutrin Roasted Peanut Splits Recalled for Possible Salmonella Contamination
Nutrin Distribution Co is recalling 40,500 lbs of Roasted Peanut Splits due to possible Salmonella contamination. The product was distributed to one customer in Pennsylvania.
Product
Nutrin/Amendobras brand Roasted Peanut Splits packaged in 30lb cardboard boxes.
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-0310-2021·2021-03-31
Adam's Secret Extra Strength Recalled for Unapproved Active Ingredients
Adam's Secret Extra Strength 1500 is being recalled because FDA analysis found unapproved drugs tadalafil and sildenafil in the product.
Product
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0313-2021·2021-03-31
ICU Medical Recalls Sodium Chloride Irrigation Due to Particulate Matter
ICU Medical is recalling 425,628 bottles of 0.9% Sodium Chloride Irrigation due to the presence of particulate matter.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1282-2021·2021-03-31
Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.
Product
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0346-2021·2021-03-31
El Abuelito Requeson Ricotta Recalled Due to Listeria Contamination Risk
El Abuelito Cheese, Inc. is recalling specific 12oz containers of Requeson Ricotta because the product may be contaminated with Listeria monocytogenes.
Product
Requeson/Ricotta, sold under the following brands and container sizes: El Abuelito Requeson Ricotta 12oz Clam Shell Container, UPC: 673130300014; El Abuelito Requeson Ricotta - Promocion $3.99 12oz. Clam Shell Container, UPC: 673130300014; El Viejito Requeson/Ricotta 12oz. Clam S
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0353-2021·2021-03-31
Gelson's Yogurt Raisins Recalled for Potential Peanut Contamination
Western Mixers Produce & Nuts, Inc. is recalling Gelson's Yogurt Raisins because the product may contain peanuts, which are not listed on the label.
Product
Gelson's Yogurt Raisins, Plastic Clamshell Container NET WT 14 oz. (397g) UPC: 7 97565 20470 6 Contains: Milk, Soy. Packed in a facility that handles Peanuts, Tree Nuts, Wheat, Soy, Egg, and Milk products. Product of USA, Distributed by Gelson's, Encino, CA
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1284-2021·2021-03-31
Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings
Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.
Product
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0312-2021·2021-03-31
Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities
Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.
Product
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-1307-2021·2021-03-31
Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect
Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.
Product
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards desi
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1280-2021·2021-03-31
Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability
Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.
Product
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0426-2021·2021-03-31
Mindo Coffee Toffee Chocolate Bar Recalled for Undeclared Milk
Mindo Chocolate Makers LLC is recalling Coffee Toffee Chocolate Bars due to undeclared milk, a major allergen. The recall covers 2,187 bars sold in Michigan and online.
Product
Mindo COFFEE TOFFEE CHOCOLATE BAR, 75 gram / 2.65oz UPC code 805993900527. Also sold in 12 count and 6 count cartons
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1299-2021·2021-03-31
Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results
Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.
Product
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1283-2021·2021-03-31
In2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
In2Bones is recalling 60 units of Shannon Percutaneous Burrs due to manufacturing non-conformity that may cause the burr to break during surgery.
Product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1281-2021·2021-03-31
RayCare 3B Oncology Software Recalled for Data Loss During Upgrade
RaySearch Laboratories AB is recalling RayCare 3B software because patient messages may be lost when upgrading from RayCare 2.
Product
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2021·2021-03-31
Olympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury
Olympus is recalling 1,564 TJF-Q190V duodenoscopes and accessories worldwide due to complaints of mucosal injury associated with the forceps elevator region.
Product
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0349-2021·2021-03-31
Taylor Farms Egg Salad Croissant Sandwich Recalled for Undeclared Soy
Taylor Farms is recalling 701 units of Egg Salad Croissant Sandwiches in Idaho, Oregon, and Washington because the label fails to declare soy lecithin.
Product
Item #140804, Egg Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 6.6 OZ (187g). UPC 0 30223 10915 0. The label is read in parts: "***Egg Salad Croissant Sandwic
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1296-2021·2021-03-31
Getinge Operating Table System Recalled for Hydraulic Leakage Risk
Getinge Group Logistics America, LLC is recalling 4,288 Operating Table Systems due to a potential hydraulic leakage that could cause unintended table movement.
Product
Operating Table System
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1289-2021·2021-03-31
Bard Marquee Biopsy Instruments Recalled for Detaching Switch
Bard Peripheral Vascular Inc is recalling Marquee Disposable Core Biopsy Instruments because the penetration depth switch may detach during use.
Product
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Category
Medical Device
Distribution
52 states
HighNHTSA·21V224000·2021-03-31
2021 Porsche Macan recalled for loose shock absorber screw connections
Certain 2021 Porsche Macan models have improperly tightened screw connections on shock absorbers, which could compromise braking and vehicle control. Porsche will repair the connections free of charge.
Product
PORSCHE — PORSCHE MACAN
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2021·2021-03-31
Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.
Product
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1293-2021·2021-03-31
Mizuho Operating Table Hand Control Units Recalled for Sliding Risk
Mizuho OSI is recalling 26 operating table hand control units because they may cause the tabletop to slide in the opposite direction, potentially delaying surgical procedures.
Product
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1285-2021·2021-03-31
Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.
Product
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0350-2021·2021-03-31
Taylor Farms Recalls Chicken Salad Croissant Sandwiches for Undeclared Soy
Taylor Farms Northwest is recalling Chicken Salad Croissant Sandwiches because the product contains soy lecithin that is not declared on the label.
Product
Item #140946, Chicken Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 7.8 OZ (221g). UPC 0 30223 11099 6. The label is read in parts: "***CHICKEN SALAD CROISSANT
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1308-2021·2021-03-31
Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect
Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.
Product
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent ca
Category
Medical Device
Distribution
0 states
HighNHTSA·21V225000·2021-03-31
Harley-Davidson motorcycles recalled for faulty headlight bulbs and visibility loss
Harley-Davidson is recalling 2019-2021 Sportster motorcycles and replacement headlight assemblies because the glass bulb may fail, causing loss of both high and low beams and increasing crash risk.
Product
HARLEY-DAVIDSON — HARLEY-DAVIDSON XL1200NS, XL1200C, XL883N, XL883L
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2021·2021-03-31
Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns
Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.
Product
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in stra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1287-2021·2021-03-31
Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.
Product
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1278-2021·2021-03-31
Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous Renal Replacement Therapy because tubing performance variability may cause alarms during or after system self-tests.
Product
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2021·2021-03-31
Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking
Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.
Product
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0351-2021·2021-03-31
Taylor Farms Recalls Tuna Salad Croissant Sandwiches for Undeclared Soy
Taylor Farms Northwest is recalling 577 units of Tuna Salad Croissant Sandwiches because the product contains soy lecithin that is not declared on the label.
Product
Item #140952, Tuna Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 7.8 OZ (221g). UPC 0 30223 11097 2. The label is read in parts: "***CHICKEN SALAD Croissant***
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1297-2021·2021-03-31
Stryker S-Series Equipment Management System Recall for Brake Disengagement Risk
Stryker is recalling S-Series Equipment Management Systems because capacitive touch controls may disengage when electrocautery devices are in use.
Product
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0352-2021·2021-03-31
Buc-ee's Butter Toffee Almonds Recalled for Peanut Mislabeling
Lehi Valley Trading Co is recalling Buc-ee's Butter Toffee Almonds because the product contains peanuts but is labeled as almonds.
Product
Buc-ee's Butter Toffee Almonds, 12 oz., packaged in clear zip top bag with stickered label, UPC: 0 9524842002 4, Manufactured and packaged at Lehi Valley Trading Company 4955 . McKellips Rd, Mesa, AZ 85215. branded and statement on label "Distributed by Buc-ee's LTD. 327 FM 2004
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1303-2021·2021-03-31
Cardinal Health Recalls Sterile Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling 936 units of sterile femoral angiography drapes because a manufacturing variance causes the plastic film to stick, preventing proper application.
Product
Femoral Angiography Drape Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1295-2021·2021-03-31
Ortho-Clinical Diagnostics Recalls VITROS TIBC Calibrator Kits Due to Performance Shift
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.
Product
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance
Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.
Product
In-View Clear Leggings Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1288-2021·2021-03-31
Siemens Recalls 29 Interventional Fluoroscopic X-Ray Systems for Shutdowns
Siemens is recalling 29 interventional fluoroscopic X-ray systems because the power supply may cause the computer to shut down unexpectedly.
Product
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1302-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Sticking Defect
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.
Product
In-View Clear Leggings Bulk Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1277-2021·2021-03-31
Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.
Product
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1304-2021·2021-03-31
Cardinal Health Recalls Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.
Product
Femoral Angiography Drape Bulk Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1290-2021·2021-03-31
Corin Trinity Hip Prosthesis Heads Recalled for Incorrect Size Labeling
Corin Ltd is recalling 23 units of Trinity Biolox Delta Ceramic Heads due to incorrect size labeling on packaging and patient stickers.
Product
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titani
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1301-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the product to stick, preventing proper application.
Product
In-View Clear Leggings Sterile Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1291-2021·2021-03-31
Corin Trinity Acetabular System Recalled for Incorrect Size Labeling
Corin Ltd is recalling 23 units of the Trinity Acetabular System because the size indicated on the packaging and patient stickers is incorrect.
Product
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1279-2021·2021-03-31
Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.
Product
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V223000·2021-03-30
2020-2021 Lincoln Aviator vehicles recalled for backup camera display failure
Ford is recalling 2020-2021 Lincoln Aviator vehicles because the backup camera display may not show video feed, affecting rear visibility. Free software updates are available from Ford dealers.
Product
LINCOLN — LINCOLN AVIATOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V220000·2021-03-30
Dennis Eagle Elite and Proview Recalled for Incorrect ABS Warning Light
Dennis Eagle is recalling 2017-2021 Elite and Proview vehicles because the ABS warning light may illuminate incorrectly when brake pads wear out, potentially causing driver confusion.
Product
DENNIS EAGLE — DENNIS EAGLE PROVIEW, ELITE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E023000·2021-03-30
Nado LED Headlight Bulb Recall for Excessive Glare and Brightness
Nado Stuff is recalling MICTUNING LED headlight bulbs that create excessive glare, increasing crash risk. Owners will receive a full refund.
Product
EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21E024000·2021-03-30
Cummins Recalls Electric Drivetrain Parts Due to High Voltage Shock Risk
Cummins is recalling Electric Drivetrain part number PD7000 because it cannot detect isolation faults, posing a high voltage shock risk to service personnel.
Product
ELECTRICAL SYSTEM:PROPULSION SYSTEM:SHOCK PROTECTION recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V221000·2021-03-30
2021 Alfa Romeo Stelvio Side Curtain Air Bag May Fail to Deploy
2021 Alfa Romeo Stelvio vehicles may have improperly crimped clamps in the side curtain air bag assembly, which can fail to deploy in a crash, increasing injury risk. Chrysler will replace the assemblies at no cost.
Product
ALFA ROMEO — ALFA ROMEO STELVIO
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V222000·2021-03-30
Pierce Recalls 2016-2018 Trucks Due to Excessively Bright Rear LED Lights
Pierce Manufacturing is recalling 2016-2018 Enforcer, Freightliner, and Saber trucks because rear LED lights may be too bright, potentially blinding other drivers.
Product
PIERCE — PIERCE FREIGHTLINER, ENFORCER, SABER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E022000·2021-03-30
BEAMTECH LED Headlight Bulbs Recalled for Excessive Glare and Brightness
Guangzhou Lengzhilu Trading Co., Ltd. is recalling specific BEAMTECH LED headlight bulbs because they create excessive glare, failing federal safety standards.
Product
EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V218000·2021-03-29
Winnebago Recalls 2020 Minnie RVs Due to Incorrect Tire Labeling
Winnebago is recalling 2020 Minnie vehicles because the Tire and Loading Information label lists the wrong tire size, which could lead to improper tire installation and increased crash risk.
Product
WINNEBAGO — WINNEBAGO MINNIE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V219000·2021-03-29
2021 Forest River Berkshire Class A Motorhomes: Brake Light Reflection Defect
Forest River is recalling certain 2021 Berkshire Class A motorhomes due to brake lights that may not adequately reflect light. The defect affects visibility and compliance with Federal Motor Vehicle Safety Standards.
Product
FOREST RIVER — FOREST RIVER BERKSHIRE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V217000·2021-03-26
Mercedes-Benz Recalls AMG Models Due to Starter Cable Fire Risk
Mercedes-Benz is recalling 493 AMG E63S and GT63 models because an incorrectly installed starter cable may chafe wires, causing a short circuit, vehicle stall, or fire.
Product
MERCEDES-BENZ — MERCEDES-BENZ AMG E63S, AMG GT63, AMG GT63S
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V216000·2021-03-26
2020 Mercedes-Benz E-Class passenger seat limiter safety recall
Mercedes-Benz is recalling certain 2020-2021 E-Class and AMG models due to a passenger seat limiter defect that may allow the seat to position too close to the frontal airbag, increasing injury risk during airbag deployment.
Product
MERCEDES-BENZ — MERCEDES-BENZ E 450, AMG E53, AMG E63S, E63 AMG
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V215000·2021-03-25
Honda and Acura Recall Vehicles for Fuel Pump Failure Risk
Honda is recalling 2018-2020 Acura and Honda vehicles because the fuel pump may fail, causing the engine to stall while driving.
Product
ACURA — ACURA, HONDA TLX, RDX, CR-V, CIVIC
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V214000·2021-03-25
RV Chassis steering column defect may cause loss of steering
Shyft Group is recalling certain 2021-2022 Spartan RV Chassis K1-K4 vehicles. A steering column defect may cause the steering output shaft to disengage, resulting in loss of steering control and crash risk.
Product
SPARTAN — SPARTAN K3, K4, K2, K1
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V213000·2021-03-25
GM Recalls 2015 Chevrolet Colorado and GMC Canyon for Steering Defect
General Motors is recalling 2015 Chevrolet Colorado and GMC Canyon vehicles because a poor electrical connection may cause loss of power steering, increasing crash risk.
Product
CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V210000·2021-03-25
2021 Chevrolet Tahoe seat belt latch may be inaccessible
GM is recalling certain 2021 Chevrolet Tahoe vehicles because the second-row center seat belt latch may be trapped beneath the trim bezel. Passengers cannot use this seat belt, increasing injury risk in a crash.
Product
CHEVROLET — CHEVROLET TAHOE
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·21732·2021-03-25
Polaris Recalls Ranger and Utility Vehicles Due to Fire Hazard
Polaris is recalling approximately 41,500 Ranger, ProXD, Gravely, and Bobcat off-road vehicles because a drive belt can break, damage the fuel line, and cause a fire.
Product
Model Year 2020-2021 RANGER 1000 and RANGER CREW 1000, Model Year 2020 ProXD 2000G and 4000G, Model Year 2020-2021 Ariens/Gravely JSV3200, JSV3400, and JSV6400, Model Year 2020 Bobcat UV34 4x4 GAS and UV34 XL GAS, and Model Year 2021 Bobcat UV34 4x4 GAS
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V212000·2021-03-25
2021 Ducati Multistrada engine valve defect increases crash risk
Certain 2021 Ducati Multistrada V4 S motorcycles may have excessive valve guide wear that could break the valve head, decreasing engine performance and increasing crash risk. Ducati will replace the affected motorcycle engines at no cost.
Product
DUCATI — DUCATI MULTISTRADA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21733·2021-03-25
KTM, Husqvarna, and GASGAS Recall Competition Motorcycles Due to Crash Hazard
KTM, Husqvarna, and GASGAS are recalling about 1,470 model year 2021 closed course competition motorcycles because the drive chain can break, posing a crash hazard.
Product
KTM, Husqvarna and GASGAS closed course competition motorcycles
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21731·2021-03-25
Inyo Pool Products Recalls PureLine Pool Pump Motors Due to Fire Hazard
Inyo Pool Products is recalling about 800 PureLine 1.5 HP pool pump motors because they can overheat and pose a fire hazard. No injuries have been reported.
Product
PureLine 1.5 HP Pool Pump Motors
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V211000·2021-03-25
Chevrolet Camaro 2017-2021 Air Bag Emblem Separation Recall
General Motors is recalling certain 2017-2021 Chevrolet Camaro vehicles because the plastic 'Camaro' emblem on the steering wheel air bag cover may separate during air bag deployment, creating a projectile hazard.
Product
CHEVROLET — CHEVROLET CAMARO
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0341-2021·2021-03-24
Kareem Mart Recalls Tahina Sesame Paste Due to Salmonella
Kareem Mart Inc is recalling Tahina Sesame Paste in 1lb, 2lb, and 10kg containers because the product tested positive for Salmonella.
Product
Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and 10kg metal containers; UPC CODES 6215000382207
Category
Food
Distribution
8 states
CriticalFDA (Devices)·Z-1195-2021·2021-03-24
Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels
Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filte
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·21V205000·2021-03-24
Tracker Recalls 2021 Trailers Due to Tire Fender Rubbing
Tracker Marine is recalling 2021 Ranger Trail and Trailstar trailers because tires may rub against fenders, causing premature wear and increasing the risk of a tire blowout.
Product
RANGER TRAIL — RANGER TRAIL, TRAILSTAR ZV20, NZ18, ZV21, NZ21
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V200000·2021-03-24
Porsche Recalls 2021 Models Due to Engine Connecting Rod Defect
Porsche is recalling 2021 Cayman, Boxster, and 718 Spyder vehicles because engine connecting rods may crack and loosen, increasing the risk of a crash or fire.
Product
PORSCHE — PORSCHE redundant CAYMAN, redundant BOXSTER, 718 SPYDER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V202000·2021-03-24
2020-2021 Ford F-53 and F-59 Motorhome Rear Bearing and Axle Defect
Ford is recalling certain 2020-2021 F-53 and F-59 motorhome and commercial chassis vehicles due to inadequate rear axle lubricant. The defect may cause rear wheel bearing damage, rear axle failure, and loss of motive power and brake function.
Product
FORD — FORD F-59, F-53
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V203000·2021-03-24
Starcraft RV Recalls 2019-2020 Travel Trailers Due to Gas Leak Risk
Starcraft RV is recalling 2019-2020 travel trailers because an overtightened bolt may damage a seal, causing a gas leak that increases fire risk.
Product
STARCRAFT RV TT — STARCRAFT RV TT MOSSY OAK LITE, AUTUMN RIDGE, GPS, LAUNCH OUTFITTER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V204000·2021-03-24
Jayco Recalls 2019-2020 Motorhomes Due to Gas Leak Risk
Jayco is recalling 2,144 motorhomes because a stove component may cause a gas leak, increasing the risk of fire.
Product
ENTEGRA — ENTEGRA, JAYCO ODYSSEY, REDHAWK, ESTEEM, GREYHAWK
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·010-2021·2021-03-24
BC Food LA Recalls Ineligible Chinese Beef Hot Pot Base Products
BC Food LA, LLC is recalling approximately 1,643 pounds of Chinese-style hot pot base products containing beef tallow imported from China, a country ineligible to export beef to the U.S.
Product
BC Food LA, LLC Recalls Ineligible Beef Products Imported From China
Category
Food
Distribution
3 states
SevereNHTSA·21C002000·2021-03-24
Diono Recalls Cambria 2 Booster Seats Due to Headrest Separation Risk
Diono is recalling specific Cambria 2 Booster Seats because the headrest may separate from the backrest in a crash, increasing injury risk.
Product
CHILD SEAT recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V206000·2021-03-24
Western Star 4700 and 5700 Ground Harness Wiring Defect
DTNA is recalling 2019-2021 Western Star 4700 and 5700 vehicles with undersized ground harness wiring that may cause connector melting and engine stall, increasing crash risk. Owners should contact DTNA for free replacement.
Product
WESTERN STAR — WESTERN STAR 4700, 5700
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1197-2021·2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is coll
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0305-2021·2021-03-24
Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.
Product
PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0303-2021·2021-03-24
Spironolactone Tablets Recalled Due to Potential Labeling Error
Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.
Product
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch P
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1192-2021·2021-03-24
Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk
Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.
Product
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1264-2021·2021-03-24
Imactis NaviKit Stereotaxic Accessory Recalled for Mechanical Defect
Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.
Product
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Category
Medical Device
Distribution
3 states
SevereFDA (Food)·F-0342-2021·2021-03-24
Alqosh Sesame Oil Tahin Recalled Due to Salmonella Contamination
Mediterranean Food, Inc. is recalling Alqosh Sesame Oil Tahin in 2lb jars because the product tested positive for Salmonella.
Product
Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1262-2021·2021-03-24
Merit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch
Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Product
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1263-2021·2021-03-24
Heartspan Transseptal Needle Recall Due to Tip Curvature Mismatch
Merit Medical Systems is recalling Heartspan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Product
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1196-2021·2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0339-2021·2021-03-24
Frozen Tuna Steaks Recalled Due to Salmonella Contamination
Seafood Imports Distributors Inc. is recalling 10 oz. frozen tuna steaks because FDA samples tested positive for Salmonella.
Product
Java Frozen Tuna Steaks - 10 oz. Net Wt. 10 lb. - Approximately 15-18 pieces individually vacuum packed. Product of Indonesia - Wild Caught.
Category
Food
Distribution
5 states
HighNHTSA·21V208000·2021-03-24
2021 Genesis GV80 High-Pressure Fuel Tube Recall: Fire Risk
Hyundai is recalling certain 2021 Genesis GV80 and G80 vehicles with 2.5-liter turbo engines due to a high-pressure fuel tube that may not seal properly, potentially allowing fuel to leak and increase fire risk.
Product
GENESIS — GENESIS GV80, G80
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V199000·2021-03-24
2021 BMW X3 and X4 Fuel Tank Weld May Separate, Increasing Fire Risk
BMW is recalling certain 2021 X3 and X4 vehicles due to a fuel tank weld that may fail, allowing fuel to leak and increasing fire risk. All repairs have been completed.
Product
BMW — BMW X3, X4
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V209000·2021-03-24
2021 Western Star 4700 and Freightliner Cascadia clutch assembly recall
Daimler Trucks North America recalls certain 2021 Western Star 4700 and Freightliner Cascadia vehicles because the clutch flange may break, causing clutch disengagement and crash risk. Dealers will replace the clutch assembly free of charge.
Product
WESTERN STAR — WESTERN STAR, FREIGHTLINER 4700, CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V207000·2021-03-24
2021 Thomas Built Buses Saf-T-Liner C2 Recalled for Damaged Valve Stems
Daimler Trucks North America is recalling 2021 Thomas Built Buses Saf-T-Liner C2 school buses because tire valve stem extensions may be damaged by brake calipers, risking tire pressure loss.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1272-2021·2021-03-24
Accuray CyberKnife Treatment Delivery System Recalled for Loose Set Screws
Accuray is recalling 243 CyberKnife Treatment Delivery Systems because set screws can loosen, allowing the treatment couch to roll unexpectedly.
Product
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21100·2021-03-24
Flame King Recalls Hog 100-Pound Propane Cylinders Due to Fire Hazard
Flame King is recalling Hog 100-pound propane cylinders because a manufacturing defect could cause gas leaks and fire. No injuries have been reported.
Product
Hog 100-pound Propane Cylinders
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·21101·2021-03-24
Beal Birdie Belay Devices Recalled Due to Risk of Climber Injury
Beal Sas is recalling about 1,400 Birdie Belay Devices because the hand lever can detach, preventing users from lowering climbers. No injuries have been reported.
Product
Beal Birdie Belay Devices
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V201000·2021-03-24
Porsche Recalls 2019-2020 911 Models for Rear Axle Screw Connection Issue
Porsche is recalling specific 2019 and 2020 911 models because a loose rear axle screw connection may fail, causing driving instability and increasing crash risk.
Product
PORSCHE — PORSCHE 911 CARRERA, 911
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E021000·2021-03-24
Guangzhou Cougar LED Headlight Bulbs Recalled for Excessive Glare
Guangzhou Cougar is recalling specific LED headlight bulbs that create excessive glare for oncoming drivers, increasing crash risk.
Product
EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2021·2021-03-24
Epimed Feth-R-Kath Catheter Recalled for Coating Deterioration
Epimed International is recalling Feth-R-Kath Catheters because the outer coating may crack or flake off. The recall covers 5,835 units distributed nationwide.
Product
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1250-2021·2021-03-24
Cardinal Health Recalls Magellan Hypodermic Safety Needles Due to Locking Failure
Cardinal Health is recalling Magellan Hypodermic Safety Needles because the safety shield may fail to lock, creating a risk of needlestick injuries and exposure to bloodborne pathogens.
Product
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2021·2021-03-24
Medtronic Pediatric Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 4 units of a pediatric cardiotomy reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1267-2021·2021-03-24
Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results
Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.
Product
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1275-2021·2021-03-24
Sirtex Medical Recalls SIROS D-Vial Prep Sets Due to Particulate Matter
Sirtex Medical Limited is recalling SIROS D-Vial Prep Sets because of a potential presence of particulate matter in the D-Vial.
Product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Category
Medical Device
Distribution
Distributed nationwide

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