September 2021 recalls

519 recalls were announced in September 2021.

What the numbers show

Critical: 6
Severe: 98
High: 317
Moderate: 90
Low: 8

Of the 519 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

Which agencies issued them

401–500 of 519

HighFDA (Devices)·Z-2396-2021·2021-09-08
Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.
Product
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2401-2021·2021-09-08
Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device
Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.
Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2385-2021·2021-09-08
Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.
Product
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2409-2021·2021-09-08
Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2383-2021·2021-09-08
CoolSculpting Elite System Software Error May Misreport Thermal Events
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-2389-2021·2021-09-08
Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2394-2021·2021-09-08
CT Pin Guide Instruments Recalled for Software Imaging Alignment Error
The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2366-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
Product
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2371-2021·2021-09-08
Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2407-2021·2021-09-08
COVID-19 diagnostic test distributed outside certified laboratory channels
CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.
Product
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by thei
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0775-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2372-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2365-2021·2021-09-08
Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2370-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2361-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2358-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2368-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Labeling and Instructions Enhancements
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2367-2021·2021-09-08
Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Product
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0774-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2373-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2364-2021·2021-09-08
Palindrome RT Repair Kit Voluntary Withdrawal for Labeling and Instructions Enhancement
Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0955-2021·2021-09-08
Raw Shelled Peanuts Recalled for Metal Contamination
OLAM Edible Nuts is recalling raw shelled peanuts due to the presence of metal objects in the product. The recall affects two lots distributed to Georgia and Illinois.
Product
Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net. Wt. 2000# Olam Edible Nuts - Blakely, GA
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2408-2021·2021-09-08
FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution
Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.
Product
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0777-2021·2021-09-08
Naproxen Sodium Tablets Recall Due to Manufacturing Quality Deviations
Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.
Product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0928-2021·2021-09-08
Flourless Chocolate Torte mislabeled with wrong product and allergen information
Gem City Fine Foods is recalling Flourless Chocolate Torte because the product is mislabeled with Triple Berry Streusel Cheesecake ingredients and nutrition information, and both products are labeled to contain pecans despite no nuts being used.
Product
Flourless Chocolate Torte, 14 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001186. Store Frozen or Thawed in Fridge.
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2362-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2359-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2360-2021·2021-09-08
Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2369-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
Product
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0787-2021·2021-09-08
Clopidogrel Tablets Recalled for Foreign Matter Contamination
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
Product
CLOPIDOGREL — CLOPIDOGREL (CLOPIDOGREL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2393-2021·2021-09-08
Steripath Luer Transport Pack Gen2 Recalled for Incorrect Instructions
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
Product
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2374-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0784-2021·2021-09-08
Donepezil HCL Tablets 5 mg Recalled for Subpotency
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
Product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0785-2021·2021-09-08
Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
Product
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2363-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2375-2021·2021-09-08
Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Category
Medical Device
Distribution
0 states
LowFDA (Food)·F-0929-2021·2021-09-08
Frozen Cheesecake and Torte Products Mislabeled with Incorrect Ingredients
Gem City Fine Foods is recalling frozen desserts with mismatched ingredient and nutrition labels, and with false pecan labeling despite no nuts being used since April 2018.
Product
Triple Berry Streusel Cheesecake, 20 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001193. Store Frozen or Thawed in Fridge.
Category
Food
Distribution
2 states
SevereNHTSA·21V694000·2021-09-07
Eldorado EZRM Recalled for Fuel Hose Leak Fire Risk
Eldorado National is recalling 2019-2021 EZRM vehicles with L9 Diesel Engines due to a fuel hose leak that increases fire risk.
Product
ELDORADO — ELDORADO EZRM
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V693000·2021-09-07
LDJ Recalls 2021 Thunder Creek Trailers Due to Fender Light Wiring Defect
LDJ Manufacturing is recalling 279 2021 Thunder Creek trailers because improperly routed wiring may cause fender clearance lights to fail, increasing crash risk.
Product
THUNDER CREEK — THUNDER CREEK STT, MTO, SLT, MTT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E084000·2021-09-04
Nineo F2-H11 LED Bulbs Recalled for Excessive Brightness
Nineo is recalling F2-H11 replacement LED bulbs because they may be too bright, posing a glare hazard to oncoming drivers.
Product
EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V691000·2021-09-03
2021 Forest River Berkshire RVs Recalled for Electrical Fire Risk
Forest River is recalling certain 2021 Berkshire recreational vehicles that may have unsealed mini-breakers in the electrical system, which could cause sparks and increase the risk of fire in the battery compartment.
Product
FOREST RIVER — FOREST RIVER BERKSHIRE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V692000·2021-09-03
2021-2022 Coachmen Nova motorhomes recalled for improper battery installation
Forest River is recalling 2021-2022 Coachmen Nova motorhomes because the Absorbed Glass Mat battery was incorrectly installed, allowing hydrogen gas to accumulate inside the vehicle and create a risk of injury.
Product
COACHMEN — COACHMEN NOVA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E083000·2021-09-03
Cummins Recalls Electric Drivetrain Systems Due to Shutdown Override Failure
Cummins is recalling specific electric drivetrain systems where the high-voltage shutdown override switch may fail to function, increasing crash risk.
Product
ELECTRICAL SYSTEM recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V686000·2021-09-02
Highland Ridge RV Recalls 1,157 Units Due to Propane Regulator Failure
Highland Ridge RV is recalling 1,157 recreational vehicles because a propane regulator may fail, causing increased pressure and fire risk.
Product
HIGHLAND RIDGE TT — HIGHLAND RIDGE TT, HIGHLAND RIDGE FW OPEN RANGE, OPEN RANGE ULTRA LITE, OPEN RANGE LIGHT, SILVERSTAR LIMITED
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V689000·2021-09-02
Freightliner Cascadia trucks recalled for potential steering linkage separation
Daimler Trucks North America is recalling 2019-2021 Freightliner Cascadia trucks due to improperly tightened drag link taper joints that could separate from the steering arm. Loss of steering control could result, increasing crash risk.
Product
FREIGHTLINER — FREIGHTLINER CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V690000·2021-09-02
Honda Recalls 2019-2020 CB500X and CBR500R Motorcycles for Brake Defect
Honda is recalling 2019-2020 CB500X and CBR500R motorcycles because excessive grease in the ABS modulator may cause a brake fluid leak, increasing crash risk.
Product
HONDA — HONDA CB500X, CBR500R
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V688000·2021-09-02
Toyota Tundra vehicles recalled due to headlight electrical circuit fire risk
Certain 2018-2021 Toyota Tundra vehicles have a headlight electrical circuit defect that may power high and low beams simultaneously, causing connector overheating and fire risk. Owners should contact Toyota or NHTSA for remedy information.
Product
TOYOTA — TOYOTA TUNDRA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V681000·2021-09-02
Indian Recalls 2020 Scout Bobber Sixty for Inoperable Brake Lights
Indian Motorcycle is recalling 2020 Scout Bobber Sixty models because an ECU update may have disabled brake lights, increasing crash risk.
Product
INDIAN — INDIAN SCOUT BOBBER SIXTY
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V685000·2021-09-02
Jayco Recreational Vehicles Recalled for Propane Regulator Fire Risk
Jayco is recalling certain 2017-2022 recreational vehicles with Winntec propane regulators that may fail and increase propane pressure, raising the risk of fire in gas appliances.
Product
JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO TRAVEL TRAILER, JAYCO SEISMIC, JAY FEATHER, EAGLE, redundant SEISMIC
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21778·2021-09-02
Step2 StepUp Sidekick Learning Towers Recalled Due to Fall Hazard
The Step2 Company is recalling StepUp Sidekick Learning Towers because the storage tray with cup holders and step can come loose, posing a fall hazard to children. Step2 has received 20 reports of the component coming loose, including one report of minor bruises from a fall.
Product
StepUp Sidekick Learning Towers
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V687000·2021-09-02
2021 Starcraft Telluride RV Propane Regulator Failure Fire Risk
Starcraft is recalling certain 2021-2022 recreational vehicles with defective Winntec propane regulators that may fail, causing increased pressure and larger flames in gas appliances, raising fire risk.
Product
STARCRAFT RV FW — STARCRAFT RV FW, STARCRAFT RV TT TELLURIDE, SUPER LITE, AUTUMN RIDGE OUTFITTER
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2285-2021·2021-09-01
Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0767-2021·2021-09-01
SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0765-2021·2021-09-01
Fludarabine Phosphate Injection Recalled Due to Sterility Concern
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
Product
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0770-2021·2021-09-01
Miss Slim capsules recalled for unapproved marketing distribution
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
Product
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0882-2021·2021-09-01
Cahills Ireland Red Wine Cheese Recalled for Listeria Risk
Cahills Farm Cheese Limited is recalling Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel cheese nationwide because it may be contaminated with Listeria monocytogenes, a serious foodborne pathogen.
Product
Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0881-2021·2021-09-01
Cahills Ireland Original Irish Porter Cheese Recalled for Listeria
Cahills Farm Cheese Limited is recalling Cahills Ireland Original Irish Porter cheese products due to possible Listeria monocytogenes contamination. The recall affects approximately 4.4 tons distributed nationwide.
Product
1. Cahills Ireland Original Irish Porter 5lbs.Waxed Deli Wheel 2. Cahills Ireland Original Irish Porter 2.4 lbs.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0884-2021·2021-09-01
Lidl Preferred Selection Red Wine Cheddar Recalled for Listeria
Cahills Farm Cheese Limited is recalling Lidl Preferred Selection Red Wine Cheddar cheese due to potential Listeria monocytogenes contamination. Consumers should not eat this product.
Product
Lidl Preferred Selection-Red Wine Cheddar - 7 oz.
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·21V679000·2021-09-01
Porsche Recalls 2013-2015 Models for Rear Axle Fracture Risk
Porsche is recalling 4,934 vehicles because rear-axle carrier side sections may fracture, potentially causing loss of control and increasing crash risk.
Product
PORSCHE — PORSCHE CAYMAN, BOXSTER, BOXSTER S
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0885-2021·2021-09-01
Wavy Lay's Original Potato Chips Recalled for Undeclared Milk
Frito-Lay is recalling Wavy Lay's Original Potato Chips with specific manufacturing codes due to possible undeclared milk. Consumers with milk allergies should not consume the affected product.
Product
Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag
Category
Food
Distribution
3 states
SevereFDA (Devices)·Z-2284-2021·2021-09-01
Monoject flush syringe recall: plunger may reintroduce air into IV lines
Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0883-2021·2021-09-01
Lidl Irish Stout Cheddar Cheese Recalled for Listeria Contamination
Lidl Preferred Selection Irish Stout Cheddar cheese may be contaminated with Listeria monocytogenes. Affected products were distributed nationwide and should not be consumed.
Product
Lidl Preferred Selection-Irish Stout Cheddar - 7 oz.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2286-2021·2021-09-01
Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0880-2021·2021-09-01
Cahills Ireland Whiskey Cheese recalled for Listeria monocytogenes contamination
Cahills Farm Cheese Limited is recalling Cahills Ireland Whiskey Cheese 5lb. Waxed Deli Wheels due to potential Listeria monocytogenes contamination. The affected product was distributed nationwide.
Product
Cahills Ireland Whiskey Cheese - 5lb. Waxed Deli Wheel
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0773-2021·2021-09-01
Trulicity autoinjector pens recalled for incorrect strength labeling
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
Product
TRULICITY — TRULICITY (DULAGLUTIDE)
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·21V684000·2021-09-01
Mack Recalls 2020-2022 MD Trucks Due to Brake Pedal Defect
Mack is recalling 2020-2022 MD trucks because a defective cotter pin may leave the brake pedal unsecured, increasing crash risk.
Product
MACK — MACK MD
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0768-2021·2021-09-01
SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0772-2021·2021-09-01
Atovaquone Oral Suspension Recalled for Temperature Abuse
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
Product
ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2354-2021·2021-09-01
Accu-Chek Inform II glucose test strips may open during shipment
Roche Diabetes Care is recalling Accu-Chek Inform II glucose test strips because vials may open during shipment, exposing strips to humidity and potentially causing inaccurate test results.
Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V682000·2021-09-01
Volvo Recalls Vehicles Due to Seat Belt Retractions Deactivating Early
Volvo is recalling specific 2021-2022 models because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Product
VOLVO — VOLVO V60CC, V90, V90CC, XC60
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21193·2021-09-01
TurboSke Kids Toddler Bike Helmets Recalled for Head Injury Risk
SKE Outdoors is recalling about 860 TurboSke Kids Toddler Bike Helmets (size small) because they do not meet U.S. CPSC federal safety standards, posing a risk of head injury. No injuries have been reported.
Product
TurboSke Kids Toddler Bike Helmets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2355-2021·2021-09-01
HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.
Product
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V683000·2021-09-01
Polestar Recalls 2021 Polestar 1 Vehicles for Seat Belt Retractions
Polestar is recalling 2021 Polestar 1 vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Product
POLESTAR — POLESTAR POLESTAR 1
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2021·2021-09-01
Philips Ingenia MRI System recalled due to incorrect pressure relief valve
Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.
Product
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2021·2021-09-01
Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve
Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.
Product
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2335-2021·2021-09-01
AUGMENT Injectable Kit Recalled for Wrong Vial Tray in Package
BioMimetic Therapeutics is recalling AUGMENT Injectable Kits (Model K30003010, Lot 1706343) because some packages contain the wrong vial tray. The recall affects 499 units distributed nationwide.
Product
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2021·2021-09-01
Orthopedic knee replacement stem: wrong size provided in mislabeled packaging
DePuy Orthopaedics recalled 7 units of ATTUNE REVISION CEMENTED STEM (16×80mm) because packages labeled as 16×80mm contained 16×130mm stems instead. This size mismatch could cause improper implantation if not caught before surgery.
Product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2340-2021·2021-09-01
Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide
W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.
Product
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Cause Helium Release
Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.
Product
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2021·2021-09-01
Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.
Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2343-2021·2021-09-01
Diagnostic MRI system recalled for pressure relief valve defect
A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.
Product
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2021·2021-09-01
Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.
Product
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2021·2021-09-01
MRI System Table Pads Missing Required Natural Rubber Allergen Label
Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.
Product
ECHELON Oval MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2353-2021·2021-09-01
Accu-Chek SmartView Test Strips May Open During Shipment
Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.
Product
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2350-2021·2021-09-01
Terumo Advanced Perfusion System Electronic Patient Gas System Recalled for Control Failure
The Terumo Advanced Perfusion System 1 Electronic Patient Gas System is recalled for intermittent initialization failures that disable the primary control interface, requiring use of backup local controls.
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0755-2021·2021-09-01
Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
Product
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0878-2021·2021-09-01
Gordon Choice Deli Style Tuna Salad Recalled for Undeclared Wheat
RMH Foods is recalling Gordon Choice Deli Style Tuna Salad (4 lb. containers) due to labeling errors that may expose consumers to undeclared wheat and tuna allergens. The product was distributed to Gordon Food Service retail stores and food service establishments across multiple states.
Product
Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled as Deli Style Tuna Salad The recalled product contains tuna salad, but it has two labels. The bottom container states Deli Style Chicken Sala
Category
Food
Distribution
13 states
HighFDA (Food)·F-0887-2021·2021-09-01
Crunchmaster Gluten-Free Crackers Recalled for Possible Glass
TH Foods Inc is recalling Crunchmaster Multi Grain Baked Gluten-Free Crackers due to possible pieces of glass in the product. The recall affects 7,056 retail units sold in Iowa, Illinois, Indiana, Minnesota, and Wisconsin.
Product
Crunchmaster Multi Grain Baked Gluten-Free Crackers 5-Seed Sesame, Amaranth, Flax, Chia & Quinoa 20 oz. UPC Code: 8-79890-00220-9
Category
Food
Distribution
5 states
HighFDA (Food)·F-0877-2021·2021-09-01
Wegmans Sunflower Crunch Chopped Salad Kit recalled for undeclared milk and wheat allergens
Wegmans Sunflower Crunch Chopped Salad Kit is being recalled because it contains undeclared milk and wheat allergens. Consumers with allergies to these ingredients should not consume the product.
Product
Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce, Sunflower Seeds, Red Cabbage, Carrot, Kale, Uncured Bacon, Green Onion with Wegmans Organic Coleslaw dressing. Washed and ready to eat. Salad and toppings: Net Wt 10.1 oz. (286 g) Dressing: N
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2332-2021·2021-09-01
Laboratory Data Management Software Recalled for Potential Patient Result Errors
Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.
Product
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2021·2021-09-01
AQUABEAM Handpiece scope tube tip may detach during procedures
PROCEPT BIOROBOTICS is recalling AQUABEAM Handpieces (model HP2000) because the scope tube tip may detach during use, potentially requiring procedural delay or additional intervention to remove the tip from the bladder or prostate.
Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Release Helium Gas
Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.
Product
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2021·2021-09-01
Accu-Chek Performa Test Strips Recalled Due to Defective Packaging
Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes treatment decisions.
Product
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2021·2021-09-01
MRI System Pressure Relief Valve Installation Error May Release Helium Gas
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
Product
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2021·2021-09-01
MRI System Pressure Valve Installation Error Poses Helium Release Risk
A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.
Product
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0886-2021·2021-09-01
Assist and Amend Digestive Enzyme Formula Dietary Supplement Recall—Undeclared Allergens
New Dawn Nutrition is recalling Assist and Amend Advanced Digestive Enzyme Formula (Lot #361551, Best By 2022) because it contains undeclared milk, wheat, and soy. Consumers with allergies to these substances are at risk of allergic reaction.
Product
Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2331-2021·2021-09-01
FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure
The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.
Product
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2337-2021·2021-09-01
ECHELON MRI System Recalled for Missing Natural Rubber Allergen Labeling
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.
Product
ECHELON MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0754-2021·2021-09-01
Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
Product
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
Category
Drug
Distribution
2 states

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