DrugApr 24, 2019
Estee Lauder Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15 recall — FDA D-1132-2019
Defective container: Ineffective seal between the cap and jar of the affected product.
Class IIIFDA: TerminatedEstee Lauder Inc.
Latest records
Latest recalls — page 1261
The newest recall records with useful source details are listed here.
DrugApr 24, 2019
Teva Pharmaceuticals USA Amoxicillin for Oral Suspension USP, 125 mg per 5 mL recall — FDA D-1205-2019
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugApr 24, 2019
Johnson Matthey Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing recall — FDA D-1252-2019
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class IIIFDA: TerminatedJohnson Matthey Inc.
DrugApr 24, 2019
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe recall — FDA D-1136-2019
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class IIFDA: TerminatedIso-Tex Diagnostics, Inc.
DrugApr 24, 2019
Dr. Reddy's Laboratories Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) recall — FDA D-1133-2019
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugApr 24, 2019
Brian P. Richardson Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages recall — FDA D-1206-2019
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile…
Class IFDA: TerminatedBrian P. Richardson
VehicleApr 18, 2019
Altima fuel pump recall — NHTSA campaign 19V316000
Nissan North America, Inc. (Nissan) is recalling certain 2019 Altima vehicles equipped with front wheel drive (FWD) and 2.5 liter engines. The fuel pump lock ring may not be fully engaged,…
fuel pumpNissan North America, Inc.
Medical DeviceApr 17, 2019
Becton Dickinson & Company Gravity IV Set with 3-port Closed Stopcock Manifold Model recall — FDA Z-1120-2019
The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceApr 17, 2019
Siemens Medical Solutions USA syngo.via syngo.CT Cardiac Planning, Model Number 10496180 recall — FDA Z-1113-2019
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceApr 17, 2019
Encore Medical Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral recall — FDA Z-1123-2019
Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain,…
Class IIFDA: TerminatedEncore Medical, Lp
Medical DeviceApr 17, 2019
Siemens Medical Solutions USA syngo.via syngo.CT Cardiac Function, Model Number 10496180 recall — FDA Z-1112-2019
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceApr 17, 2019
Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code recall — FDA Z-1118-2019
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceApr 17, 2019
Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm) recall — FDA Z-1100-2019
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Class IIFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceApr 17, 2019
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and recall — FDA Z-1111-2019
Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Class IIFDA: TerminatedBeaver Visitec
Medical DeviceApr 17, 2019
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott recall — FDA Z-1103-2019
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Class IIFDA: TerminatedAbbott Laboratories, Inc.
Medical DeviceApr 17, 2019
DePuy Orthopaedics CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro recall — FDA Z-1129-2019
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceApr 17, 2019
Philips Azurion FlexArm, 722079 recall — FDA Z-1130-2019
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceApr 17, 2019
Integra bioBLOCK Resorbable subtaler Implant, 11mm recall — FDA Z-1090-2019
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Class IIFDA: TerminatedIntegra Limited
Medical DeviceApr 17, 2019
Randox Laboratories Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 recall — FDA Z-1106-2019
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Class IIIFDA: TerminatedRandox Laboratories Ltd.
Medical DeviceApr 17, 2019
PROCEPT BIOROBOTICS AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a recall — FDA Z-1110-2019
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable…
Class IIFDA: TerminatedPROCEPT BIOROBOTICS CORPORATION
Medical DeviceApr 17, 2019
Integra bioBLOCK Resorbable subtaler Implant, 12mm recall — FDA Z-1091-2019
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Class IIFDA: TerminatedIntegra Limited
Medical DeviceApr 17, 2019
DePuy Orthopaedics CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro recall — FDA Z-1128-2019
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceApr 17, 2019
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott recall — FDA Z-1104-2019
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Class IIFDA: TerminatedAbbott Laboratories, Inc.
Medical DeviceApr 17, 2019
Roche Diagnostics cobas c 111 with ISE analyzers analyzer used in the following assays recall — FDA Z-1125-2019
COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Class IIFDA: TerminatedRoche Diagnostics Corporation
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026182 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