Medical DeviceSep 21, 2022
ICU Medical MicroClave Clear Neutral Connector recall — FDA Z-1719-2022
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Class IIFDA: OngoingICU Medical, Inc.
Latest records
Latest recalls — page 679
The newest recall records with useful source details are listed here.
Medical DeviceSep 21, 2022
Exactech GXL acetabular liners, orthopedic hip implant component recall — FDA Z-1727-2022
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceSep 21, 2022
ICU Medical 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check recall — FDA Z-1724-2022
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceSep 21, 2022
Cook Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER recall — FDA Z-1709-2022
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Class IIFDA: OngoingCook Inc.
Medical DeviceSep 21, 2022
Zap Surgical Systems ZAP-X Radiosurgery System recall — FDA Z-1742-2022
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and…
Class IIFDA: OngoingZap Surgical Systems
Medical DeviceSep 21, 2022
Cook Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER recall — FDA Z-1708-2022
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Class IIFDA: OngoingCook Inc.
Medical DeviceSep 21, 2022
Philips Medical Systems (Cleveland) Pinnacle3 Radiation Therapy Planning System, Model recall — FDA Z-1744-2022
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on…
Class IIFDA: OngoingPhilips Medical Systems (Cleveland) Inc.
Medical DeviceSep 21, 2022
ICU Medical MicroClave Clear Neutral Connector recall — FDA Z-1722-2022
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceSep 21, 2022
Exactech GXL acetabular liners, orthopedic hip implant component recall — FDA Z-1728-2022
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceSep 21, 2022
Cook Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 recall — FDA Z-1715-2022
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Class IIFDA: OngoingCook Inc.
Medical DeviceSep 21, 2022
ICU Medical 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock recall — FDA Z-1723-2022
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Class IIFDA: OngoingICU Medical, Inc.
FoodSep 21, 2022
General Nutrition GNC Vitamin B-6 100mg 100 VEGETARIAN TABLETS DIETARY recall — FDA F-1734-2022
The firm was notified by a customer that the bottle contains green and white capsules instead of the usual white round tablets. They contacted their manufacturer to investigate the issue…
Class IIIFDA: TerminatedGeneral Nutrition Inc.
FoodSep 21, 2022
West Thomas Partners, LLC. dba Gluten Free Bar The GFB Gluten Free Bites Dark Chocolate and recall — FDA F-1733-2022
Undeclared cashews
Class IFDA: TerminatedWest Thomas Partners, LLC. dba Gluten Free Bar
FoodSep 21, 2022
KRAFT HEINZ FOODS COMPANY Capri Sun, Wild Cherry, Flavored Juice Drink Blend in 6floz recall — FDA F-1735-2022
cleaning solution, which is used on food processing equipment, was inadvertently introduced into a production line
Class IIFDA: TerminatedKRAFT HEINZ FOODS COMPANY
DrugSep 21, 2022
Vi-Jon equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape recall — FDA D-1501-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
CITROMA EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE recall — FDA D-1502-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
CITROMA Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz) recall — FDA D-1508-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
Edgewell Personal Care Brands Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF recall — FDA D-0212-2024
Chemical contamination: presence of benzene
Class IFDA: TerminatedEdgewell Personal Care Brands, LLC
DrugSep 21, 2022
Vi-Jon Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution recall — FDA D-1510-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
SUPERIOR GLOVE WORKS Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria recall — FDA D-1537-2022
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class IIFDA: TerminatedSUPERIOR GLOVE WORKS, LTD.
DrugSep 21, 2022
CITROMA Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ recall — FDA D-1512-2022
CGMP Deviations
Class IIFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
Vi-Jon CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon recall — FDA D-1500-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
CITROMA Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon recall — FDA D-1506-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
DrugSep 21, 2022
Vi-Jon SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz) recall — FDA D-1507-2022
Microbial contamination of non-sterile products.
Class IFDA: TerminatedVi-Jon, LLC
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October 2026110 records · 3 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories