Medical DeviceJul 15, 2020
Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system recall — FDA Z-2493-2020
Potential risk of patient mix-up on analyzers due to software issues.
Class IIFDA: TerminatedRadiometer Medical ApS
Latest records
Latest recalls — page 1004
The newest recall records with useful source details are listed here.
Medical DeviceJul 15, 2020
Kentec Medical Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes recall — FDA Z-2517-2020
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Class IIFDA: TerminatedKentec Medical, Inc.
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product recall — FDA Z-2526-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
Tomtec Imaging Systems Gmbh TOMTEC-ARENA TTA2;software version no. 2.20 and lower recall — FDA Z-2496-2020
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one…
Class IIFDA: OngoingTomtec Imaging Systems Gmbh
Medical DeviceJul 15, 2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number recall — FDA Z-2539-2020
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the…
Class IIFDA: TerminatedOrthoPediatrics Corp
Medical DeviceJul 15, 2020
TeDan Surgical Innovations 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage recall — FDA Z-2524-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
FoodJul 15, 2020
Power Selles Imports dba Culinary Collective Blanxart 85% Nicaragua Organic Dark Chocolate recall — FDA F-1016-2020
A foreign object found by a consumer in dark chocolate bar.
Class IIFDA: TerminatedPower Selles Imports dba Culinary Collective
FoodJul 15, 2020
Fresh Express Chopped Kit SOUTHWEST TOTAL NET WT recall — FDA F-1017-2020
The firm learned that, during a single production run, incorrect condiment packets were placed into Southwest Chopped Kit bags and, as a result, the allergens wheat, soy, cashews, and…
Class IFDA: TerminatedFresh Express Incorpated
DrugJul 15, 2020
Cetrotide recall — FDA D-1379-2020
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class IIFDA: TerminatedEMD Serono, Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle recall — FDA D-1373-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
DrugJul 15, 2020
VistaPharm Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. recall — FDA D-1378-2020
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugJul 15, 2020
VistaPharm Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL recall — FDA D-1377-2020
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle recall — FDA D-1375-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
DrugJul 15, 2020
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle recall — FDA D-1381-2020
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class IIIFDA: TerminatedBiogen MA Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle recall — FDA D-1374-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
Medical DeviceJul 8, 2020
LivaNova USA Vein Irrigation Cannula with blunt tip recall — FDA Z-2463-2020
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceJul 8, 2020
LivaNova USA Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24 recall — FDA Z-2443-2020
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceJul 8, 2020
Ortho Clinical Diagnostics VITROS 3600 Immunodiagnostic System - Refurbished Product Code recall — FDA Z-2481-2020
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Class IIFDA: TerminatedOrtho Clinical Diagnostics
Medical DeviceJul 8, 2020
Radiometer Medical ApS ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI recall — FDA Z-2467-2020
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode…
Class IIFDA: TerminatedRadiometer Medical ApS
Medical DeviceJul 8, 2020
LivaNova USA Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24 recall — FDA Z-2445-2020
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceJul 8, 2020
Westmed Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask recall — FDA Z-2436-2020
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant…
Class IIFDA: TerminatedWestmed, Inc.
Medical DeviceJul 8, 2020
LivaNova USA Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24 recall — FDA Z-2446-2020
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceJul 8, 2020
LivaNova USA Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for recall — FDA Z-2449-2020
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceJul 8, 2020
Radiometer Medical ApS ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI recall — FDA Z-2468-2020
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode…
Class IIFDA: TerminatedRadiometer Medical ApS
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026180 records · 4 categoriesSeptember 2026363 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