August 2023 recalls

693 recalls were announced in August 2023.

What the numbers show

Critical: 15
Severe: 87
High: 526
Moderate: 65

Of the 693 recalls this month scored against our rubric, 2% are Critical, 13% are Severe.

Which agencies issued them

301–400 of 693

SevereCPSC·23256·2023-08-10
Sensio Electric and Stovetop Pressure Cookers Recalled for Burn Hazard
Sensio Inc. is recalling approximately 860,000 electric and stovetop pressure cookers because the lid can unlock and be removed during use, causing hot contents to splash out and burn consumers. The company has received 63 incident reports, including 61 burn injuries with some involving second and third degree burns.
Product
Electric and stovetop pressure cookers
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·23780·2023-08-10
Polaris RZR XP Turbo and Turbo S Off-Road Vehicles Clutch Fracture Fire Injury
Polaris recalls about 27,300 Model Year 2021 RZR XP Turbo and RZR Turbo S recreational off-road vehicles because the clutch can fracture and eject fragments, causing fires and injuries. Owners should stop using the vehicles and contact Polaris for a free clutch replacement.
Product
Model Year 2021 RZR XP Turbo and RZR Turbo S Recreational Off-Road Vehicles
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V568000·2023-08-10
Land Rover Recalls One 2023 Range Rover PHEV for Battery Fire Risk
Jaguar Land Rover is recalling one 2023 Range Rover PHEV because a high-voltage battery bolt may be loose, creating a fire risk.
Product
LAND ROVER — LAND ROVER RANGE ROVER PHEV
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V571000·2023-08-10
Autocar Recalls 2023 Xpeditor and Legend Vehicles for Driveline Bearing Defect
Autocar is recalling 2023 Xpeditor and Legend vehicles because the powertrain driveline center support bearing hardware may not be properly secured, which could cause the driveline to detach.
Product
AUTOCAR — AUTOCAR XPEDITOR, LEGEND
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V572000·2023-08-10
Moto Guzzi Recalls 2023 V100 Mandello Models for Rear Shock Absorber Defect
Piaggio Group Americas is recalling 260 2023 Moto Guzzi V100 Mandello and Mandello Aviazione motorcycles because a missing bushing may cause the rear shock absorber to break.
Product
MOTO GUZZI — MOTO GUZZI V100 MANDELLO AVIAZIONE, V100 MANDELLO
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V570000·2023-08-10
Maserati Recalls 2023 MC20 Cielo for Windshield Frame Sealant Defect
Maserati is recalling 59 2023 MC20 Cielo vehicles because missing windshield frame sealant may reduce roof strength and body structure performance in a crash.
Product
MASERATI — MASERATI MC20 CIELO
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V566000·2023-08-10
2022-2023 Toyota Tundra Fuel Tube Chafing Damage Recall
Toyota is recalling 2022-2023 Tundra and Tundra Hybrid vehicles because the plastic fuel tube may chafe against brake lines and leak fuel, creating a fire risk.
Product
TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23258·2023-08-10
Polaris, Bobcat, and Gravely Off-Road Vehicles Recalled for Fire Hazard
Polaris Industries is recalling about 12,300 off-road vehicles and fuel system parts because a fuel leak can occur at the fuel pump outlet connector near a hot surface, posing a fire hazard. No fires or injuries have been reported to date.
Product
Polaris Off-Road Vehicles, Bobcat and Gravely Utility Vehicles, Fuel Pump Kits and Fuel Tank Assemblies
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23260·2023-08-10
Red Apple Fireworks recalled for premature explosion and burn hazards
13131 Imports is recalling Red Apple Fireworks brand "American Glory" and "Merica AF" shell fireworks due to risk of premature explosion and burn injuries. The firm has received 72 reports of premature explosions, though no injuries have been reported.
Product
Fireworks
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23781·2023-08-10
Restwell Room & Board Crib Mattresses Recalled for Suffocation Hazard
Restwell Mattress Co. is recalling about 100 Room & Board brand crib mattresses because they fail to meet federal safety standards and pose a suffocation hazard to infants. Consumers should stop using the mattresses and contact Room & Board for a refund.
Product
Room & Board Natural Organic Latex and Latex and Spring Crib Mattresses
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23257·2023-08-10
The Children's Place Baby and Toddler Boy Jeans Recalled for Choking Hazard
The Children's Place is recalling about 97,400 units of Baby and Toddler Boy Basic Stretch Straight Leg Jeans because metal snaps can detach, posing a choking hazard to young children. No injuries have been reported.
Product
Baby and Toddler Boy Basic Stretch Straight Leg Jeans
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·23V564000·2023-08-10
Isuzu Recalls 2023-2024 NPR and Chevrolet LCF Trucks for Electrical Defect
Isuzu is recalling 19,479 trucks because a wire seal defect may allow water intrusion, causing fuse corrosion and potential loss of engine power.
Product
ISUZU — ISUZU CHEVROLET LCF 4500HG, CHEVROLET LCF 5500XG, N-SERIES, CHEVROLET LCF 3500HG
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V565000·2023-08-10
2023 Jeep Wrangler Brake Light Obstruction Recall
Chrysler is recalling certain 2023 Jeep Wrangler vehicles because the spare tire may obstruct the center high-mount brake light, reducing visibility to other drivers and increasing crash risk.
Product
JEEP — JEEP WRANGLER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V567000·2023-08-10
2022-2023 Chevrolet Bolt EV air bag deployment defect recall
General Motors is recalling certain 2022-2023 Chevrolet Bolt EV vehicles because the instrument panel cover may lack a required perforation, preventing proper passenger-side air bag deployment.
Product
CHEVROLET — CHEVROLET BOLT EV
Category
Vehicle
Distribution
Distributed nationwide
ModerateCPSC·23255·2023-08-10
Target Recalls 2.2 Million Threshold Glass Jar Candles for Laceration and Burn Hazards
Target is recalling about 2.2 million Threshold Glass Jar Candles because the glass jars can crack or break during use, posing laceration and burn hazards. Target received 19 reports of jars breaking or cracking, resulting in one minor injury.
Product
Threshold Glass Jar Candles
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·23259·2023-08-10
Saxco International Recalls Glass Carboys Due to Laceration Hazard
Saxco International is recalling about 8,370 glass carboys because the glass can break due to improper cooling processes, posing a laceration hazard. The firm has received 30 reports of incidents of glass breaking, though no injuries have been reported.
Product
Carboys
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2023·2023-08-09
Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1081-2023·2023-08-09
Prescription Birth Control Tablets Recalled for Failed Stability Testing
Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.
Product
TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1303-2023·2023-08-09
Pamana Brand Lychee Jelly Cups recalled for potential choking hazard
Foremost Foods International, Inc. is recalling Pamana Brand Mini Fruit Jelly Cup in Lychee flavor due to a potential choking hazard affecting 11,040 units distributed in the United States and Canada.
Product
Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Lychee Flavor 6 units per case Item #416704
Category
Food
Distribution
0 states
SevereUSDA FSIS·036-2023·2023-08-09
E.N.A. Meat Packing Recalls Frozen Raw Beef and Lamb Products
E.N.A. Meat Packing Inc. is recalling approximately 58,721 pounds of frozen, raw beef and lamb products produced without federal inspection. Consumers in New Jersey and New York should discard these items.
Product
E.N.A. Meat Packing Inc. — E.N.A. Meat Packing Inc. Recalls Frozen, Raw Beef and Lamb Products Produced Without Benefit of Inspection
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1302-2023·2023-08-09
Pamana Mini Fruit Jelly Cup Recalled Due to Choking Hazard
Foremost Foods International, Inc. is recalling Pamana brand Mini Fruit Jelly Cups (11,040 units) distributed in the United States and Canada due to a potential choking hazard. Consumers should stop using the product immediately.
Product
Pamana brand Mini Fruit Jelly Cup 35.27 oz. Assorted Flavors 6 units per case Item #416705
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1304-2023·2023-08-09
Pamana Brand Mini Fruit Jelly Cups Recalled for Choking Hazard
Foremost Foods International is recalling Pamana Brand Mini Fruit Jelly Cups due to a potential choking hazard. Approximately 11,040 units distributed in the United States and Canada are affected.
Product
Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Mango Flavor 6 units per case Item #416706
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-1075-2023·2023-08-09
FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process
Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.
Product
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1061-2023·2023-08-09
Fentanyl Injectable Solution Recalled for Sterility Validation Failure
Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.
Product
fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0973-2023·2023-08-09
FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1338-2023·2023-08-09
Dark Chocolate Pecans Recalled for Potential Undeclared Tree Nuts and Peanuts
Houston Pecan Company is recalling dark chocolate pecans in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies should not consume the product.
Product
Dark Chocolate Pecans packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Food)·F-1342-2023·2023-08-09
Valencia Orange Slices Recalled for Undeclared Tree Nuts, Peanuts, Wheat
Houston Pecan Company recalls Valencia Orange Slices for potential undeclared tree nuts, peanuts, and wheat due to allergen cross-contamination. Five-pound bags sold in Texas and online before May 25, 2023 may be affected.
Product
Valencia Orange Slices, Oranges, Sugar, Citric Acid, SO2 packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0962-2023·2023-08-09
FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.
Product
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1002-2023·2023-08-09
Neonatal TPN IV Bags Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services recalled 96 neonatal TPN IV bags (Lot 36-256336) due to lack of sterility assurance and missing validation data for decontamination cycles. The product was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2321-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline is recalling 233,638 procedural kits containing Turkuaz ultrasound gel that may not meet sterility specifications. The potentially non-sterile gel could pose infection risks during medical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1026-2023·2023-08-09
IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Product
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0997-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1004-2023·2023-08-09
Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 224 neonatal TPN starter bags (250mL IV bags) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1012-2023·2023-08-09
FDA recalls oxytocin-lactated ringer IV bags due to sterility concerns
Central Admixture Pharmacy Services recalls 33,073 bags of oxytocin 30 units with Lactated Ringer's 500 mL IV solution nationwide due to lack of validated sterilization. No illnesses reported.
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2023·2023-08-09
Medline Probe Cover Kits recalled for potential sterility specification failure
Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.
Product
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2023·2023-08-09
MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction
Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.
Product
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Pr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0999-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0966-2023·2023-08-09
Vancomycin IV Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 3,648 bags of vancomycin IV bags due to lack of assurance of sterility caused by insufficient validation data for decontamination cycles.
Product
vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1038-2023·2023-08-09
Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.
Product
CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1021-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0981-2023·2023-08-09
Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Product
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2336-2023·2023-08-09
Medline Procedural Kits Recalled Due to Sterility Specification Concerns
Medline Industries is recalling 211 custom procedural kits (egg retrieval, fetal surgery, TVT packs) worldwide because the sterile ultrasound gel component may not meet sterility specifications. Kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0998-2023·2023-08-09
Neonatal TPN Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1020-2023·2023-08-09
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2023·2023-08-09
Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction
Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2023·2023-08-09
X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts
Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.
Product
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2023·2023-08-09
Custom procedural kits recalled for potential sterility failure in ultrasound gel
Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1016-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
Product
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2023·2023-08-09
Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction
Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1298-2023·2023-08-09
Plantation Candies Petite Misty Mints Recalled for Undeclared Soy Allergen
Plantation Candies, Inc. is recalling Petite Misty Mints because the product contains undeclared soy, a major allergen. The product was distributed in Washington, Massachusetts, Michigan, North Dakota, and Pennsylvania.
Product
Plantation Candies Petite Misty Mints 10 lbs and 25 lb boxes Packaged in plastic bags inside cardboard boxes
Category
Food
Distribution
5 states
HighFDA (Food)·F-1347-2023·2023-08-09
Prima Guida Sheeted Pizza Dough recalled for undeclared soy flour allergen
Cassanos Inc is recalling Prima Guida Traditional Homestyle Sheeted Pizza Dough in multiple sizes due to undeclared soy flour. Consumers with soy allergies should not consume this product.
Product
Prima Guida Traditional Homestyle Sheeted Pizza Dough: packaged as 7in, 8in, 9in, 10in (regular), 10in (thin), 12in (thin), 12in (regular), 14 in (regular), 14in (thin), 16in (thin), 16in (regular), 18in
Category
Food
Distribution
9 states
HighFDA (Drugs)·D-0957-2023·2023-08-09
Epinephrine IV Bags Recalled Due to Unvalidated Sterility Process
Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.
Product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1041-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1017-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1064-2023·2023-08-09
Morphine Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.
Product
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0950-2023·2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.
Product
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1359-2023·2023-08-09
Mondelez Recalls belVita Breakfast Sandwich Due to Undeclared Peanut Allergen
Mondelez Global LLC is recalling belVita Breakfast Sandwich products because they may contain undeclared peanut allergen due to cross contamination. The recall affects approximately 445,264 cases distributed nationwide.
Product
belVita Breakfast Sandwich, Dark Chocolate Creme variety (6 - 8.8 oz. cartons)
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0951-2023·2023-08-09
FDA recalls dilTIAZem IV bags due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0953-2023·2023-08-09
IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1363-2023·2023-08-09
Mondelez Recalls belVita Breakfast Sandwiches for Undeclared Peanut Allergen
Mondelez Global LLC is recalling belVita Breakfast Sandwiches (Dark Chocolate Creme variety) because they contain an undeclared peanut allergen due to cross contamination. Consumers with peanut allergies should not consume this product.
Product
belVita Breakfast Sandwich, Dark Chocolate Creme variety (192 - 2 lb 12 oz cartons per pallet)
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2262-2023·2023-08-09
Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction
Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1337-2023·2023-08-09
Pitted Prunes Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company is recalling 5-pound bags of pitted prunes that may contain undeclared tree nuts, peanuts, and wheat. The affected product was sold in Texas and online prior to May 25, 2023.
Product
Pitted Prunes, May contain pits or pit fragments packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2263-2023·2023-08-09
Olympus Forceps Model INS-0362 Navigation Sensor Malfunction During Procedures
Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0996-2023·2023-08-09
Neonatal TPN solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1023-2023·2023-08-09
Cardioplegia Solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2023·2023-08-09
CT Scanner Metal Mounting Box May Become Expelled, Posing Injury Risk
Philips is recalling Incisive CT Plus imaging systems due to a metal mounting box that may separate from the rotating scanner and potentially injure users.
Product
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0976-2023·2023-08-09
FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.
Product
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2304-2023·2023-08-09
Medline Procedural Kits Recalled for Potentially Non-Sterile Gel
Medline Industries is recalling 1,218 procedural kits because the sterile ultrasound gel component may not meet sterility specifications, potentially posing an infection risk in invasive procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0954-2023·2023-08-09
EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance
Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1014-2023·2023-08-09
Neonatal TPN Starter Bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0985-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2023·2023-08-09
Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
Product
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1071-2023·2023-08-09
Ketamine Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.
Product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2313-2023·2023-08-09
Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1008-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2023·2023-08-09
Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns
Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile Procedural Kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2023·2023-08-09
Medline Procedural Kits Recalled Due to Sterility Specification Failure
Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1343-2023·2023-08-09
Sweet & Salty Mix Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company is recalling Sweet & Salty Mix 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. All bags purchased before May 25, 2023 are affected.
Product
Sweet & Salty Mix, Rst & Salted Peanuts, Rst & Salted Cashews, Raisins, Cranberries, Sunflower Seeds, Pumpkin Seeds, Sliced Almonds packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1046-2023·2023-08-09
FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1036-2023·2023-08-09
Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency
Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1056-2023·2023-08-09
Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.
Product
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1028-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1040-2023·2023-08-09
Cardioplegia Solution IV Bags Recalled Due to Sterility Assurance
Central Admixture Pharmacy Services is recalling 72 bags of Cardioplegia Solution due to insufficient validation data for product sterilization processes.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure
Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2254-2023·2023-08-09
Zimmer Periarticular Locking Plate recalled due to thread form defect
Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.
Product
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular cond
Category
Medical Device
Distribution
10 states
HighFDA (Drugs)·D-1074-2023·2023-08-09
Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns
CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.
Product
lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1060-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.
Product
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1312-2023·2023-08-09
Mediterranean Salad Recalled for Undeclared Allergens Including Milk
Eat Good LLC is recalling Mediterranean Salad distributed in Idaho, Montana, and Washington due to missing allergen declarations for milk, sulfites, and FD&C Yellow #5.
Product
Mediterranean Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Mediterranean Sal
Category
Food
Distribution
3 states
HighFDA (Food)·F-1340-2023·2023-08-09
Breakfast Treats Recall: Potential Undeclared Allergen Contamination
Houston Pecan Company is recalling 5-pound bags of Breakfast Treats with Almonds, Walnuts & Dark Raisins due to potential undeclared peanuts, wheat, and tree nuts from cross-contamination. Affected products were purchased before May 25, 2023, and sold in Texas and online.
Product
Breakfast Treats, Sliced Almonds, Walnuts & Dark Raisins packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Food)·F-1348-2023·2023-08-09
DOUBLEDAY'S Premium Dough Recalled for Undeclared Soy Allergen
DOUBLEDAY'S Premium Dough packages may contain undeclared soy flour, posing risk to consumers with soy allergies. The recall affects 24,575 cases distributed across nine states.
Product
DOUBLEDAY'S Premium Dough on Parchment: packaged as 8in, 9in, 10in, 12 in
Category
Food
Distribution
9 states
HighFDA (Drugs)·D-0986-2023·2023-08-09
FDA Recalls OxyTOCIN IV Bags Over Sterility Assurance Defect
FDA recalls 130,250 bags of oxyTOCIN IV solution from CAPS, Inc., distributed nationwide, due to lack of validated sterilization procedures. No illnesses reported.
Product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1003-2023·2023-08-09
FDA Recalls OxyTOCIN IV Bags Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 497 bags of OxyTOCIN IV bags nationwide due to lack of validated sterility assurance. The manufacturer's decontamination validation data is insufficient.
Product
oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1080-2023·2023-08-09
Morphine Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising sterility.
Product
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1035-2023·2023-08-09
Cardioplegia Solution Recalled Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lacking validation data for decontamination cycles, creating insufficient assurance of sterility in this injectable product.
Product
CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2023·2023-08-09
ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems
A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.
Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1320-2023·2023-08-09
Shredded Coconut Recalled for Undeclared Tree Nuts, Peanuts, and Wheat Allergens
Houston Pecan Company recalls shredded coconut due to potential undeclared allergen cross-contamination with tree nuts, peanuts, and wheat. Affected consumers with allergies should not consume the product.
Product
Shredded Coconut Sulfur Dioxide added packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2272-2023·2023-08-09
Cardiac Surgery Device Blade May Fail to Latch Securely During Use
The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.
Product
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1039-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot 36-254906) due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1
Category
Drug
Distribution
Distributed nationwide

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