September 2022 recalls

527 recalls were announced in September 2022.

What the numbers show

Critical: 21
Severe: 145
High: 306
Moderate: 53
Low: 2

Of the 527 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

Which agencies issued them

101–200 of 527

ModerateFDA (Devices)·Z-1770-2022·2022-09-28
Dialysis water-treatment unit recalled for missing ferrite cores in cables
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.
Product
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1753-2022·2022-09-28
Strawberry, Kiwi, and Mango Products Recalled Due to Inadequate Sanitizer
Russ Davis Wholesale is recalling strawberry, kiwi, and mango products sold under the Crazy Fresh and Strawberry Sunrise brands due to inadequate sanitizer in wash water. Products were distributed across six Midwestern states.
Product
Strawberry, Kiwi, Mango. Packaged in the following brands and sizes: 1. Item 80595. Net Wt. 14 oz. Crazy Fresh 2. Item 80866. Net Wt 20 oz. Crazy Fresh, quick & easy, and grocery store branded. 3. Item 89269. Strawberry Sunrise Net Wt. 16 oz. Kowalski's Markets 4.
Category
Food
Distribution
6 states
ModerateFDA (Food)·F-1777-2022·2022-09-28
Summer Daze fruit salad recalled due to inadequate wash water sanitization
Russ Davis Wholesale LLC is recalling Summer Daze fruit mixture products sold at Kowalski's Markets in the Midwest due to inadequate sanitizer used in wash water during processing.
Product
Summer Daze. Contains: Cantaloupe, Watermelon, Pineapple, Grapes, Blueberries. Keep Refrigerated. Packaged in the following brands and sizes: 1. Item 89270. Net Wt. 16 oz. Kowalski's Markets. 2. Item 89279. Net Wt. 40 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
SevereNHTSA·22E082000·2022-09-27
Manchester Tank Recalls Propane Tanks Due to Valve Thread Depth Defect
Manchester Tank & Equipment Co is recalling ManTank Propane Tanks because valve thread depth is less than spec, creating a risk of propane leaks and fire.
Product
EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22E081000·2022-09-27
Haldex Air Disc Brake Pads Recalled for Loose Retaining Clip
Haldex is recalling certain ModulT Gen II Air Disc Brakes because a loose retaining clip may detach, creating a road hazard and increasing crash risk.
Product
SERVICE BRAKES, AIR:DISC:PADS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V720000·2022-09-27
Lightning eMotors Recalls 2022 FE4 and FT3 for Brake Warning Light Defect
Lightning eMotors is recalling 2022 FE4 and FT3 vehicles because the instrument panel may fail to display brake and ABS warning lights, increasing crash risk.
Product
LIGHTNING EMOTORS — LIGHTNING EMOTORS FE4, FT3
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V719000·2022-09-26
Seagrave Recalls 2022 Emergency Vehicles Due to Tie Rod Clamp Defect
Seagrave is recalling 2022 Marauder and Capitol emergency vehicles because improperly heat-treated tie rod clamps may fail, causing a loss of steering.
Product
SEAGRAVE — SEAGRAVE CAPITAL, MARAUDER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V718000·2022-09-26
2023 Volkswagen Atlas Models Recalled for Brake Line Leaks
Volkswagen is recalling 2023 Atlas and Atlas Cross Sport models due to brake lines that may leak at threaded connections. A brake fluid leak can increase stopping distance, raising crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V717000·2022-09-26
Doosan Recalls 2021-2022 Portable Air Compressors Due to Brake Seal Leak
Doosan is recalling 2021-2022 Portable Air Compressors because wheel bearing seals may leak grease into drum brakes, reducing braking performance and increasing crash risk.
Product
DOOSAN — DOOSAN PORTABLE AIR COMPRESSOR
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·034-2022·2022-09-24
Behrmann Meat and Processing Inc. Recalling Ready-to-Eat Meat Products Due to Listeria Contamination
Behrmann Meat and Processing Inc. is recalling approximately 87,382 pounds of ready-to-eat meat products because tests detected possible Listeria monocytogenes contamination. No confirmed cases of illness have been reported since the September 24, 2022 recall announcement.
Product
Behrmann Meat & Processing, Inc. — Behrmann Meat and Processing Inc. Recalls Various Ready-to-Eat Meat Products Due to Possible Listeria Contamination
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·22V716000·2022-09-23
McNeilus Recalls 2021-2023 Zero Radius Trucks Due to Weld Failure Risk
McNeilus is recalling 2021-2023 Zero Radius trucks because ejector welds may fail, causing hydraulic cylinders to penetrate the truck body and increasing injury risk.
Product
MCNEILUS — MCNEILUS ZERO RADIUS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V715000·2022-09-23
Micro Bird Recalls School Buses Due to Fire Risk from Loose Cable
Micro Bird is recalling 2,753 school buses because a loose power cable connection may cause the air conditioning control board to overheat and melt, increasing the risk of a fire.
Product
MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, T-SERIES SCHOOL BUS, MB II SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·033-2022·2022-09-23
Empanadas Valrico Recalls Beef and Chicken Empanadas Produced Without Inspection
Empanadas Valrico Inc. is recalling approximately 6,247 pounds of frozen beef and chicken empanadas produced without federal inspection. The products were distributed in Florida.
Product
Empanadas Valrico Inc. Recalls Beef and Chicken Empanada Products Produced Without Benefit of Inspection
Category
Food
Distribution
Distributed nationwide
HighNHTSA·22V714000·2022-09-23
Micro Bird Transit Bus Recall for Air Conditioning Fire Risk
Micro Bird is recalling 2012-2022 transit buses because a loose power cable connection to the air conditioning control board may overheat and cause a fire.
Product
MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS, G5 TRANSIT BUS, MB II TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V711000·2022-09-22
Navistar Recalls 2022-2023 International HX Trucks for Steering Defect
Navistar is recalling 2022-2023 International HX vehicles because improperly heat-treated tie rod clamps may fail, causing loss of steering and increasing crash risk.
Product
INTERNATIONAL — INTERNATIONAL HX
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·22227·2022-09-22
Spalding Momentous EZ Portable Basketball Goals Recalled for Impact Injury Risk
Russell Brands is recalling about 13,400 Spalding Momentous EZ Portable Basketball Goals because welds in the arm attaching the backboard to the pole can fail, causing the backboard to fall and strike users. The firm has received 26 reports of weld failures and 2 injury reports.
Product
Spalding Momentous EZ Portable Basketball Goals
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·22V709000·2022-09-22
2020-2021 GMC Acadia rearview camera may fail due to improper connector crimping
General Motors is recalling certain 2020-2021 GMC Acadia vehicles with defective rearview camera coaxial cables that may fail or malfunction. The improperly crimped connectors can reduce rear visibility and increase crash risk.
Product
CADILLAC — CADILLAC, GMC XT5, XT6, ACADIA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22773·2022-09-22
Pool and Spa Drain Covers Recalled for Entrapment Hazard
Chyir Myd pool and spa drain covers do not meet federal entrapment-protection standards and pose a hazard to swimmers. About 300 units were sold on Amazon from September 2021 through June 2022.
Product
Pool and spa drain covers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·22775·2022-09-22
Pool and Spa Drain Covers Recalled for Entrapment Hazard
Goetas pool and spa drain covers do not meet the Virginia Graeme Baker Pool and Spa Safety Act standards, creating an entrapment hazard for swimmers and bathers. About 300 units were sold on Amazon from October 2021 through April 2022.
Product
Pool and spa drain covers
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·22V710000·2022-09-22
2023 Cadillac LYRIQ Instrument Panel Software Error May Cause Display to Go Blank
General Motors is recalling certain 2023 Cadillac LYRIQ vehicles due to a software error that may cause the instrument panel display to go blank, potentially preventing drivers from seeing critical safety information.
Product
CADILLAC — CADILLAC redundant LYRIQ
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V708000·2022-09-22
2023 Cadillac XT6, XT5, and GMC Acadia: illegible tire certification label
General Motors is recalling 2023 Cadillac XT6, XT5, and GMC Acadia vehicles due to illegible tire size information on the driver's side certification label. The illegibility may result in incorrect tires being installed, increasing crash risk.
Product
CADILLAC — CADILLAC, GMC XT6, XT5, ACADIA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22777·2022-09-22
Canyon Furniture Ladders Recalled for Entrapment and Strangulation Hazards
Canyon Furniture Company is recalling approximately 2,100 ladders sold with Canyon Lake and Cottage Colors bunk bed and hutch sets due to a gap wider than 3.5 inches between the fourth ladder step and the hutch cross-member that poses entrapment and strangulation hazards. No injuries have been reported.
Product
Ladders sold with Canyon Lake and Cottage Colors Bunk Bed and Hutch Sets
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·22V713000·2022-09-22
Osage Recalls 2022 Warrior Emergency Vehicles Due to Lighting Failure Risk
Osage Industries is recalling 2022 Warrior and Super Warrior emergency vehicles because a defective circuit board can cause vehicle lighting to fail, increasing crash risk.
Product
OSAGE — OSAGE WARRIOR, SUPER WARRIOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V712000·2022-09-22
2022 Subaru Outback Windshield Defect May Cause Detachment in Crash
Subaru is recalling 42 2022 Outback and Impreza vehicles due to incorrect paint clearcoat that may insufficiently bond the windshield. The windshield could detach during a crash, increasing injury risk.
Product
SUBARU — SUBARU OUTBACK, IMPREZA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22776·2022-09-22
Pool and Spa Drain Covers Recalled for Entrapment Hazard
Angzhili pool and spa drain covers do not meet the Virginia Graeme Baker Pool and Spa Safety Act entrapment protection standards, posing a risk to swimmers and bathers. About 1,000 units sold on Amazon from June 2021 through June 2022 are affected.
Product
Pool and spa drain covers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·22774·2022-09-22
Wadoy pool and spa drain covers recalled for entrapment hazard
Find4Fix has recalled about 5,500 Wadoy eight-inch pool and spa drain covers sold on Amazon from August 2019 through June 2022 because they do not meet Virginia Graeme Baker Pool and Spa Safety Act entrapment protection standards.
Product
Pool and spa drain covers
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22226·2022-09-22
Miffy First LED Lights Recalled for Overheat Burn Hazard
About 1,400 Miffy First LED Lights can overheat during use, posing a burn hazard. No injuries have been reported. Consumers should stop using the lights and contact the company for a free module replacement.
Product
Miffy First LED Lights
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22228·2022-09-22
Accompany USA Ceramic Mugs with Cork Bottoms Recall Due to Burn Hazard
Accompany USA is recalling about 25,000 ceramic mugs with cork bottoms because they can crack or break when hot liquid is poured into them, posing a burn hazard. One incident of breakage has been reported with no injuries.
Product
Ceramic Mugs with Cork Bottoms
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1509-2022·2022-09-21
Walgreens Dye-Free Magnesium Citrate Laxative Recalled for Microbial Contamination
Vi-Jon, LLC is recalling Walgreens Dye-Free Magnesium Citrate Saline Laxative due to microbial contamination of the non-sterile product. Approximately 29,172 bottles distributed nationwide in the USA, Canada, and Panama are affected.
Product
Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8166-38 UPC 3 11917 20160 3 (green label)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1504-2022·2022-09-21
Meijer Magnesium Citrate Laxative Recalled for Microbial Contamination
Meijer brand magnesium citrate laxative (10 fl oz) has been recalled nationwide due to microbial contamination of Lot 0557622. Consumers should discard or return the product.
Product
meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1500-2022·2022-09-21
CVS Health Magnesium Citrate Saline Laxative recalled for microbial contamination
CVS Health Magnesium Citrate Saline Laxative is being recalled due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles were distributed nationwide.
Product
CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1728-2022·2022-09-21
Spicy shrimp rolls recalled for undeclared egg allergen
EZ Noble Sushi is recalling spicy shrimp rolls (8 oz) with expiration 08/12/2022 due to undeclared egg. This poses a serious risk to consumers with egg allergies.
Product
Spicy shrimp roll (8 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
CriticalFDA (Drugs)·D-1540-2022·2022-09-21
Propofol Injectable Emulsion Recalled for Particulate Matter Contamination
Pfizer is recalling 5,390 vials of Propofol Injectable Emulsion due to the presence of particulate matter. The affected lot (EA7470, expiration 6/1/2023) was distributed nationwide.
Product
PROPOFOL — PROPOFOL (PROPOFOL)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1506-2022·2022-09-21
FDA Recalls Citroma Magnesium Citrate Laxative for Microbial Contamination
Citroma magnesium citrate laxative is recalled due to microbial contamination. The FDA Class I recall affects 42,912 bottles distributed in the USA, Canada, and Panama.
Product
CITROMA — CITROMA (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1731-2022·2022-09-21
Shrimp tempura and lobster roll recalled for undeclared wheat allergen
EZ Noble Sushi is recalling shrimp tempura and lobster roll products with expiration date 08/12/2022 distributed in Massachusetts and Connecticut due to undeclared wheat allergen.
Product
Shrimp tempura & lobster roll (12.8 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1726-2022·2022-09-21
Spicy salmon rolls recalled for undeclared egg allergen
EZ Noble Sushi recalls spicy salmon rolls (9.6 oz, expiration 08/12/2022) sold in MA and CT due to undeclared egg allergen.
Product
Spicy salmon roll (9.6 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1730-2022·2022-09-21
EZ Noble Sushi Rolls Recalled for Undeclared Egg Allergen
EZ Noble Sushi is recalling Pink Lady and Salmon Avocado rolls (9 oz, expiration 08/12/2022) distributed in MA and CT due to undeclared egg. Consumers with egg allergies should not consume this product.
Product
Pink lady and salmon avocado roll (9 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-1501-2022·2022-09-21
Equate Magnesium Citrate Saline Laxative Recalled Due to Microbial Contamination
Equate Magnesium Citrate saline laxative has been recalled for microbial contamination. The FDA Class I recall affects 18,324 bottles distributed in the US, Canada, and Panama.
Product
equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc. Bentonville, AR 72716; NDC 49035-592-38 UPC 6 81131 28715 9
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1510-2022·2022-09-21
Walgreens Magnesium Citrate Laxative Recalled for Microbial Contamination
Walgreens Dye-Free Magnesium Citrate Saline Laxative is recalled nationwide due to microbial contamination affecting certain lots. Consumers should stop using the product immediately.
Product
Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015; NDC 0363-7162-38 UPC 3 11917 20159 7 (purple label).
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1508-2022·2022-09-21
OTC Magnesium Citrate Laxative Recalled for Microbial Contamination
Vi-Jon's CITROMA magnesium citrate laxative is recalled due to microbial contamination. Approximately 18,588 bottles were distributed nationwide in the USA, Canada, and Panama.
Product
CITROMA — CITROMA (MAGESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1507-2022·2022-09-21
SWAN Citroma Saline Laxative Recalled for Microbial Contamination
Vi-Jon is recalling SWAN Citroma Magnesium Citrate Saline Laxative (10 FL OZ bottles) due to microbial contamination of a non-sterile product. The product was distributed nationwide in the USA, Canada, and Panama.
Product
SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; NDC 0869-0166-38 UPC 0 72785 13405 8
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1505-2022·2022-09-21
Magnesium Citrate Laxative Recalled Due to Microbial Contamination
Vi-Jon's Magnesium Citrate oral solution laxative is recalled nationwide due to microbial contamination. Approximately 8,682 bottles are affected.
Product
MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1732-2022·2022-09-21
Sushi Rolls Recalled for Undeclared Wheat Allergen Content
EZ Noble Sushi is recalling California crunch roll products due to undeclared wheat allergen. Consumers with wheat allergies should discard this product.
Product
California crunch roll (9.6 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-1503-2022·2022-09-21
FDA Recalls Kroger Magnesium Citrate Laxative for Microbial Contamination
Kroger-branded Magnesium Citrate saline laxative is being recalled due to microbial contamination. The recall affects approximately 44,976 bottles distributed in the USA, Canada, and Panama.
Product
MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1725-2022·2022-09-21
Shrimp Tempura Sushi Rolls Recalled for Undeclared Egg and Wheat
EZ Noble Sushi is recalling Shrimp Tempura and spice shrimp rolls (11.2 oz, expiration 08/12/2022) due to undeclared egg and wheat allergens. Consumers with allergies to eggs or wheat should not consume this product.
Product
Shrimp Tempura and spice shrimp roll (11.2 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1733-2022·2022-09-21
GFB Gluten Free Bites Dark Chocolate and Coconut recalled for undeclared cashews
West Thomas Partners is recalling The GFB Gluten Free Bites Dark Chocolate and Coconut (UPC 856818008895) because the product contains undeclared cashews. Consumers with cashew allergies should not consume this product.
Product
The GFB Gluten Free Bites Dark Chocolate and Coconut 1.2oz. UPC 856818008895, 10 retail units per tray, 6 trays per wholesale case.
Category
Food
Distribution
25 states
SevereFDA (Devices)·Z-1653-2022·2022-09-21
Baxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.
Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1502-2022·2022-09-21
FDA Recalls CITROMA Magnesium Citrate for Microbial Contamination
Vi-Jon, LLC is recalling CITROMA magnesium citrate oral laxative solution due to microbial contamination. The affected product was distributed nationwide in the USA, Canada, and Panama.
Product
CITROMA — CITROMA (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1727-2022·2022-09-21
EZ Noble Sushi Spicy Tuna Roll Recalled for Undeclared Egg Allergen
EZ Noble Sushi is recalling Spicy Tuna Roll (9.6 oz) with expiration 08/12/2022 due to undeclared egg. Consumers with egg allergies should not consume this product.
Product
Spicy tuna roll (9.6 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0212-2024·2022-09-21
Banana Boat Clear Sunscreen Spray recalled for benzene contamination
Edgewell Personal Care Brands is recalling Banana Boat hair & scalp defense Clear Sunscreen Spray SPF 30 due to benzene contamination. The affected product was distributed nationwide in the United States.
Product
Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·22E080000·2022-09-21
Dexter Axle Recalls Smart-Steer 2.0 Axles Due to Steering Arm Fracture Risk
Dexter Axle is recalling Smart-Steer 2.0 self-steering axles because the steering arm may fracture, potentially causing a crash.
Product
STEERING recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V705000·2022-09-21
Volvo Recalls 2022-2023 VNRE Electric Trucks Due to Battery Fire Risk
Volvo Trucks North America is recalling 2022-2023 VNRE electric vehicles because a coolant line defect may cause an electrical short circuit and fire.
Product
VOLVO — VOLVO VNRE (ELECTRIC)
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V706000·2022-09-21
Mack Recalls One 2021 LR Electric Truck for Battery Fire Risk
Mack Trucks is recalling one 2021 LR Electric truck because a coolant line may not be fully seated, creating a risk of electrical short circuit and fire.
Product
MACK — MACK LR ELECTRIC
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1519-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.
Product
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1538-2022·2022-09-21
Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination
RemedyRepack Inc. is recalling Lisinopril 10 mg prescription tablets due to a metal fragment embedded in one tablet. Affected lots were distributed to pharmacies in Pennsylvania and Alaska.
Product
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1516-2022·2022-09-21
MIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.
Product
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1521-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.
Product
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1536-2022·2022-09-21
Lisinopril Tablets Recalled for Embedded Metal Contamination
Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.
Product
LISINOPRIL — LISINOPRIL (LISINOPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1520-2022·2022-09-21
Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue
Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.
Product
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1537-2022·2022-09-21
Hand Sanitizer Recalled for Manufacturing Defects and Chemical Impurities
Superior Glove Works is recalling Synergy Hand Sanitizer due to acetaldehyde impurity and excess total impurities above specification limits. The 80% alcohol topical antiseptic was distributed nationwide.
Product
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy S
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1533-2022·2022-09-21
FDA Recalls Injectable Medication Due to Sterility Assurance Failure
Carolina Infusion's QUAD-MIX 30/2/60/0.15 injectable (Lot 08022022@12) is recalled nationwide because the manufacturer failed to assure sterility. Patients and healthcare providers should not use affected vials and should contact the manufacturer.
Product
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1735-2022·2022-09-21
Capri Sun juice drink recalled for accidental cleaning solution contamination
Capri Sun Wild Cherry juice drinks are being recalled because cleaning solution inadvertently entered the production line. The affected product has a best-by date of June 25, 2023.
Product
Capri Sun, Wild Cherry, Flavored Juice Drink Blend in 6floz. foil pouch. Sold in carton containing 10 pouches. Carton UPC 087684001004. Four cartons per wholesale case.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1714-2022·2022-09-21
Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2022·2022-09-21
Vascular wire guides recalled due to potential sterility compromise
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2022·2022-09-21
Laboratory device displays incorrect sample volume guidance during setup
A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.
Product
QIAcube Connect MDx, Model No. 9003070
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-1706-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise
Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2022·2022-09-21
Sterile Dental Rolls Recalled: New Cotton Source Sterility Not Validated
Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.
Product
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2022·2022-09-21
Subdermal Needle Electrodes Recalled Due to Burn Risk During MRI Procedures
Technomed Europe is recalling disposable subdermal needle electrodes because patients may suffer burns if electrodes are left in place during MRI scanning. The manufacturer failed to provide adequate safety information in the device instructions.
Product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1532-2022·2022-09-21
TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.
Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2022·2022-09-21
GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2022·2022-09-21
Vascular Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1717-2022·2022-09-21
Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2022·2022-09-21
Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2022·2022-09-21
ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment
A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.
Product
ZAP-X Radiosurgery System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2022·2022-09-21
Pinnacle3 Radiation Therapy Planning System dose-calculation software error
Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1722-2022·2022-09-21
ICU Medical Recalls Intravascular Connectors for Manufacturing Defect
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
Product
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1715-2022·2022-09-21
Vascular catheter wire guide recalled for sterility testing failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1527-2022·2022-09-21
TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.
Product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1525-2022·2022-09-21
FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance
Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.
Product
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1531-2022·2022-09-21
Injectable drug recalled due to lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.
Product
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2022·2022-09-21
Extension Set Recall Due to Connector Housing Manufacturing Defect
ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.
Product
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1526-2022·2022-09-21
Injectable Drug Recall: TRI-MIX 30/1/10 Vials Lack Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/10 injectable vials nationwide because the sterility of the product cannot be assured. This FDA Class II recall affects 16 vials distributed across multiple lots with expiration dates through October 2022.
Product
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1539-2022·2022-09-21
Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling
Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1518-2022·2022-09-21
Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.
Product
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1523-2022·2022-09-21
Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns
Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.
Product
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1528-2022·2022-09-21
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.
Product
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1729-2022·2022-09-21
Philadelphia Sushi Rolls Recalled for Undeclared Milk Allergen
EZ Noble Sushi is recalling Philadelphia avocado and cucumber classic rolls (8 oz) with expiration 08/12/2022 due to undeclared milk. The rolls were distributed in Massachusetts and Connecticut.
Product
Philadelphia avocado or cucumber classic roll (8 oz) with expiration 08/12/2022
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-1529-2022·2022-09-21
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.
Product
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1522-2022·2022-09-21
Injectable testosterone product recalled for sterility assurance defect
Carolina Infusion is recalling TEST CYP 200 MG/ML Injectable due to the manufacturing process's inability to assure sterility. The affected lots were distributed nationwide; patients should not use the product.
Product
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1524-2022·2022-09-21
Injectable Steroid Product Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.
Product
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1517-2022·2022-09-21
Injectable drug product recalled for lack of sterility assurance
Carolina Infusion is recalling MIC/B12/L-Carn (HD) injectable vials due to inability to assure product sterility. The product was distributed nationwide.
Product
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1515-2022·2022-09-21
L-Carnitine Injectable Recalled Due to Sterility Assurance Failure
Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.
Product
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2022·2022-09-21
Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags
Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2022·2022-09-21
SCENARIA View software error may require additional patient radiation exposure
SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.
Product
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1732-2022·2022-09-21
Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear
Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1514-2022·2022-09-21
Injectable Anesthetic Solution Recalled for Lack of Sterility Assurance
Pine Pharmaceuticals is recalling Bupivacaine and Lidocaine injectable solutions for eye anesthesia due to lack of assurance of sterility. The product was distributed to direct accounts in four states.
Product
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Park
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-1720-2022·2022-09-21
ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 states
HighNHTSA·22V707000·2022-09-21
2022-2023 Volkswagen Golf R and GTI radiator defect recall
Volkswagen is recalling 2022-2023 Golf R and Golf GTI vehicles because the radiator may not be properly attached to the intercooler, potentially causing coolant leaks, engine overheating, and fire risk.
Product
VOLKSWAGEN — VOLKSWAGEN GOLF R, GTI
Category
Vehicle
Distribution
Distributed nationwide

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