Medical DeviceJun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm recall — FDA Z-2384-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
June 2020 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceJun 24, 2020
Angiodynamics BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for recall — FDA Z-2397-2020
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Class IIFDA: TerminatedAngiodynamics, Inc.
Medical DeviceJun 24, 2020
Abaxis Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 recall — FDA Z-2361-2020
Incorrect reference ranges of analytes.
Class IIFDA: TerminatedAbaxis Inc.
Medical DeviceJun 24, 2020
Stryker End Cap, Std, Ti Gamma3 recall — FDA Z-2387-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJun 24, 2020
Stryker End Cap T2 Tibia +10 mm recall — FDA Z-2375-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJun 24, 2020
Resource Optimization & Innovation Regard SRHS Central Line Kit, Sterile, 20/case - Product recall — FDA Z-2369-2020
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Class IIFDA: TerminatedResource Optimization & Innovation LLC
Medical DeviceJun 24, 2020
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and recall — FDA Z-2391-2020
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Medical DeviceJun 24, 2020
Medtronic Sofamor Danek USA Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an recall — FDA Z-2389-2020
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Medical DeviceJun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm recall — FDA Z-2380-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJun 24, 2020
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and recall — FDA Z-2390-2020
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Medical DeviceJun 24, 2020
Defibtech DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA recall — FDA Z-2392-2020
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Class IIFDA: TerminatedDefibtech, LLC
Medical DeviceJun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm recall — FDA Z-2383-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJun 24, 2020
Angiodynamics BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are recall — FDA Z-2398-2020
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Class IIFDA: TerminatedAngiodynamics, Inc.
Medical DeviceJun 24, 2020
Ortho-Clinical Diagnostics VITROS Chemistry Product Performance Verifier I, Product Code recall — FDA Z-2366-2020
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV)…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceJun 24, 2020
GE Healthcare Giraffe Incubator with installed Servo Oxygen module recall — FDA Z-2236-2020
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 24, 2020
Defibtech DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN recall — FDA Z-2394-2020
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Class IIFDA: TerminatedDefibtech, LLC
Medical DeviceJun 24, 2020
Stryker Compression Screw, Advanced T2 Tibia recall — FDA Z-2374-2020
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJun 24, 2020
Angiodynamics BioFlo Midline Convenience Kits - Product Usage: These introducers are used recall — FDA Z-2396-2020
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Class IIFDA: TerminatedAngiodynamics, Inc.
FoodJun 24, 2020
Captain Rusty's Seafood Products Made with real Lobster meat, Keep Refrigerated,16 oz recall — FDA F-0997-2020
Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Lobster Dip uncovered during FDACS routine inspection.
Class IFDA: TerminatedCaptain Rusty's Seafood Products LLC
FoodJun 24, 2020
Captain Rusty's Seafood Products A Taste of the Pacific Coast, Keep Refrigerated, 16 oz recall — FDA F-0994-2020
Undeclared major allergen (milk) in "Captain Rusty's" brand Smoked Salmon Dip uncovered during FDACS routine inspection.
Class IIFDA: TerminatedCaptain Rusty's Seafood Products LLC
FoodJun 24, 2020
Captain Rusty's Seafood Products Made with real Blue Crab and Lobster meat, Keep recall — FDA F-0996-2020
Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Cajun Crab & Lobster Dip uncovered during FDACS routine inspection.
Class IFDA: TerminatedCaptain Rusty's Seafood Products LLC
FoodJun 24, 2020
Captain Rusty's Seafood Products Made with real Blue Crab meat, Keep Refrigerated,16 oz recall — FDA F-0998-2020
Undeclared major allergens (fish, egg, soy, milk, and wheat) in "Captain Rusty's" brand Blue Crab Dip uncovered during FDACS routine inspection.
Class IFDA: TerminatedCaptain Rusty's Seafood Products LLC
FoodJun 24, 2020
Captain Rusty's Seafood Products Made with real Mahi meat, Keep Refrigerated, 6 lb recall — FDA F-0995-2020
Undeclared major allergens (egg and soy) in "Captain Rusty's" brand Smoked Mahi Dip uncovered during FDACS routine inspection.
Class IFDA: TerminatedCaptain Rusty's Seafood Products LLC
DrugJun 24, 2020
AVKARE Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count recall — FDA D-1304-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedAVKARE Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.