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AmniSure International LLC

AmniSure International LLC Recalls

All product recalls associated with AmniSure International LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 33541–33560 of 37665 recalls

AmniSure International LLC: AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vi...

Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"

FDAOct 3, 2007Nationwide• AmniSure International LLC

Stryker Communications: Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable...

Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.

FDAOct 3, 2007Nationwide• Stryker Communications

Acist Medical Systems: ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612;...

Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.

FDA

1...1676 167716781679 1680...1884

Page 1678 of 1884Next

Oct 3, 2007

Nationwide

• Acist Medical Systems

Rita Medical Systems, Inc.: Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, ...

Incorrect Size Catheter: The product may contain an incorrect size catheter.

FDAOct 3, 2007AL, AR, CA +8 more• Rita Medical Systems, Inc.

Varian Medical Systems Inc: Varian brand VARiS 1.4g (Medical Charged Particle Radiati...

Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.

FDAOct 2, 2007Nationwide• Varian Medical Systems Inc

Toshiba American Med Sys Inc: Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA...

Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.

FDAOct 2, 2007Nationwide• Toshiba American Med Sys Inc

Gas Valves (Honeywell) – Burn Hazard in Fireplaces (2007)

Fire/Burn Risk

This recall involves gas valves used in liquid-propane-fueled decorative fireplaces and Franklin-type stoves. These stoves and fireplaces have direct pressure relief vents via a spring-loaded door. Fireplaces and stoves with a side or rear vent are not included in this recall. The recalled valves were installed in these fireplaces and stoves. Manufacturer Name/Model Fireplace or Stove Kozy Heat Fireplaces Chaska Fireplace Chaska XL Fireplace 911 Fireplace 911XL Fireplace 911XXL Fireplace 932 Fireplace 936 Fireplace SP36 Fireplace 942 Fireplace 944 Fireplace 961 Fireplace Windom (56101) Fireplace Thief River Falls (TRF) Fireplace Two Harbors Fireplace Princeton Fireplace Minnetonka Fireplace Lakefield Stove Breckenridge Stove Duluth Stove KLS Gas Log Conversion Fireplace Empire Comfort/White Mountain Hearth Tahoe Remote RF - models ADVP36FP91P, ADVP36FP93P, ADVP42FP91P, ADVP42FP93P, ADVP48FP91P, ADVP48FP93P, DVP36FP91P, DVP36FP93P, DVP42FP91P, DVP42FP93P, DVP48FP91P, and DVP48FP93P Fireplaces Flame International (SBI) GTX-I, model number GX700 Stove Blaze King (US) Valley Comfort (Canada) The Eclipse 2205 Fireplace Central Fireplace (Central Boiler) CF-3036MV Fireplace CF-22DVI Fireplace Montigo (Canadian Heating Products) 34DVI Tuscany Fireplace Lennox Hearth Products EDVI30 Fireplace EDVI35 Fireplace Mendota Hearth /Johnson Gas Appliance Co All Fireplace or Stove Harji's Fireplace Manufacturing LTD All Fireplace or Stove Inca Metal Cutting LTD All Fireplace or Stove

CPSCOct 2, 2007Nationwide• Honeywell International Inc., of Morristown, N.J.

Boston Scientific Corp: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 ...

The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.

FDAOct 1, 2007Nationwide• Boston Scientific Corp

Medtronic Neuromodulation: Medtronic Kinetra 7428, Dual Program Neurostimulator for ...

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

FDAOct 1, 2007AL, AK, AZ +46 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Soletra 7426, Quadripolar Multi-Programmable Ne...

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

FDAOct 1, 2007AL, AK, AZ +46 more• Medtronic Neuromodulation

Medtronic Perfusion Systems: Medtronic Trillium Affinity NT, 541T, Integrated CVR/Mem...

Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

FDAOct 1, 2007Nationwide• Medtronic Perfusion Systems

Toshiba American Med Sys Inc: Toshiba America Medical Systems (TAMS) Aquilion 32 CT sys...

Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.

FDAOct 1, 2007Nationwide• Toshiba American Med Sys Inc

GE Healthcare: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR ...

A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.

FDAOct 1, 2007AL, AZ, CA +32 more• GE Healthcare

GE Healthcare: GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127...

A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.

FDAOct 1, 2007AL, AZ, CA +32 more• GE Healthcare

Medtronic Perfusion Systems: Medtronic Blood Collection Reservoir, 40 micron,Catalog/M...

Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

FDAOct 1, 2007Nationwide• Medtronic Perfusion Systems

Abbott Laboratories: Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 te...

Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.

FDAOct 1, 2007Nationwide• Abbott Laboratories

Toshiba American Med Sys Inc: Toshiba-Interventional Angiography System, Infinix i, Mod...

System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

FDAOct 1, 2007Nationwide• Toshiba American Med Sys Inc

Stryker Howmedica Osteonics Corp.: Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high of...

Mis-labeling; The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

FDASep 28, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Hipstar TMZF Cementless Hip Stem Protocol, Product Number...

Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.

FDASep 28, 2007Nationwide• Stryker Howmedica Osteonics Corp.

GE OEC Medical Systems, Inc: GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model...

Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

FDASep 28, 2007CO, DE, FL +6 more• GE OEC Medical Systems, Inc