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Pointe Scientific, Inc.

Pointe Scientific, Inc. Recalls

All product recalls associated with Pointe Scientific, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

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 17181–17200 of 21320 recalls

Pointe Scientific, Inc.: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Sc...

R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.

FDAJul 29, 2009CA• Pointe Scientific, Inc.

Draeger Medical Systems, Inc.: Heater Elements for Resuscitaire Infant Radiant Warmers m...

Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

FDAJul 29, 2009Nationwide• Draeger Medical Systems, Inc.

Medtronic Xomed, Inc.: Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450...

Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.

1...858 859860861 862...1066

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FDAJul 27, 2009Nationwide• Medtronic Xomed, Inc.

Novasys Medical Inc: Renessa RF System, model PR0918, manufactured by Novasys ...

Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation

FDAJul 27, 2009Nationwide• Novasys Medical Inc

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Virtuoso VR, Model D154VWC, Single Chamber impl...

Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.

FDAJul 27, 2009Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implan...

FDAJul 27, 2009Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Xomed, Inc.: Repose G2 Bone Screw System, Sterile, REF 76353200; Lot #...

FDAJul 27, 2009Nationwide• Medtronic Xomed, Inc.

Neuro Kinetics: VEST 6.6 or earlier software for use with Neuro Kinetics ...

Marketed without a 510k or PMA submission to include the normative data display.

FDAJul 24, 2009AL, AZ, CA +19 more• Neuro Kinetics

Cyberonics, Inc: Cyberonics VNS Therapy Programming M250 Programming Syste...

Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists.

FDAJul 24, 2009PR• Cyberonics, Inc

Siemens Medical Solutions USA, Inc.: Siemens ACUSON X300 Systems with software versions 3.0.00...

Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.

FDAJul 24, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Siemens ACUSON X300 Premium Edition Systems with software...

Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.

FDAJul 24, 2009CA, CT, FL +2 more• Siemens Medical Solutions USA, Inc.

Sevylor Tow Behinds – connector break risk (2009)

The recall involves the following model Sevylor® Tow Behinds with Quick Hitch component. The Quick Hitches were manufactured between 2005 and 2009. Model No. Description 2000002098 Avenger ST2467 Daytona U362YEL Daytona U346RED Devil Ray ST9007 Double Threat U350BLK Double Threat U350GRN Double Threat ST2607 Drag'n Master U363RED Drag'n Master ST9401 Flight Blaster U338RED Flight Blaster ST2000 Le Biscuit U371RED Le Biscuit ST2540 Raging Racer U382PUR Raging Racer ST2650 Super Blaster U384BLU Super Blaster U384RED Super Blaster ST9300WM Triple Blaster ST9300 Triple Threat U351RED Triple Threat ST9050 Twin Blaster U349YEL Twin Blaster ST9075 Velocity Blaster U353YEL Velocity Blaster ST2467WM Wake Zone U362CMB Wake Zone

CPSCJul 23, 2009Nationwide• Shanghai Suofeng Plastic Metal Manufactures Co., Ltd., China

Newport Medical Instruments Inc: Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H...

The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has a slightly higher amperage draw than the single battery and as a result can cause the fuse in the external battery pack to blow making the battery inoperable.

FDAJul 22, 2009Nationwide• Newport Medical Instruments Inc

Roche Diagnostics Operations, inc.: Roche CoaguChek XS System, CoaguChek XS Professional Care...

The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

FDAJul 22, 2009Nationwide• Roche Diagnostics Operations, inc.

Orthopediatrics Corp: Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-st...

The potential exists for the nails to fracture during insertion of the nail.

FDAJul 21, 2009Nationwide• Orthopediatrics Corp

Boston Scientific CRM Corp: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization...

Laceration Risk

Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.

FDAJul 20, 2009AZ, CA, CT +18 more• Boston Scientific CRM Corp

Boston Scientific Corporation: Prolieve Thermodilatation Catheter Kit, a Transurethral M...

Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.

FDAJul 20, 2009Nationwide• Boston Scientific Corporation

Boston Scientific CRM Corp: Boston Scientific TELIGEN, Implantable Cardiac Defibrilla...

Laceration Risk

FDAJul 20, 2009AZ, CA, CT +18 more• Boston Scientific CRM Corp

Medtronic Xomed, Inc.: Medtronic Integrated Power Console System, IP X1 REF 189...

An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.

FDAJul 17, 2009Nationwide• Medtronic Xomed, Inc.

Mako Surgical Corporation: 200996-Cable Assembly, Hybrid Extended Length, 200997 Ca...

Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System.

FDAJul 17, 2009Nationwide• Mako Surgical Corporation