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Access CardioSystems

Access CardioSystems Recalls

All product recalls associated with Access CardioSystems.

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Recall Summary

Total Recalls

1000

Past Year

898

Class I (Serious)

125

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 16841–16860 of 17592 recalls

Access CardioSystems: AccessAED (without audio record) Model Number: 9100-0100-0

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessALS (Advanced Life Support) Model Number: 9100-0100-2

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessALS Package Model Number: 9100-0150-2

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

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Access CardioSystems: AccessAED Package (without audio record) Model Number: 9...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessAED (with audio record) Model Number: 9100-0100-1

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Bard Access Systems, Inc: Intraoperative Ultrasound Cover Kit

Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Access CardioSystems: AccessAED Package (with audio record) Model Number: 9100...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessAED PAD Package (without ECG trace) Model Number: ...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Bard Access Systems, Inc: Site-Rite Sterile Needle Guide Kit - 18 gauge

Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Salsa Campeon Bicycle Forks (Quality Bicycle Products) – Carbon Fiber Defect (2004)

The recall involves carbon fiber/aluminum forks included with the Salsa model F-01 Campeon frame set in either White/Black or Red/Black color combinations. Units included in this recall have a code of CK, DA, or DB and a serial number from 03400 to 04600. The model number, date code and serial number are located on a label at the base of the steerer tube near the crown of the fork.

CPSCNov 2, 2004Nationwide• Quality Bicycle Products, Inc., of Bloomington, Minn.

Beckman Coulter Inc: CXP software for Cytomics FC500 Cytometer

Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.

FDANov 2, 2004Nationwide• Beckman Coulter Inc

Robertshaw TS-11 Gas Valve (Robertshaw) – Commercial Equipment Risk (2004)

The TS-11 Thermal Safety Control Gas Valves are installed in commercial cooking equipment with pilot lights, including ranges, griddles, fryers, and warming trays. The recalled gas valves were produced between February 2003 and August 2004. The "magnet heads" on the gas valves were made during the same range of dates. The recalled products can be identified by date codes 0306 through and including 0432. The TS-11 gas valve with different manufacturing dates and a different hazard was recalled in 2002.

CPSCNov 1, 2004Nationwide• Robertshaw Controls Company of Long Beach, California

Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vesse...

Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.

FDAOct 29, 2004FL, HI, IL +10 more• Beckman Coulter Inc

Boston Scientific Scimed: RunWay 6F Cardiovascular Guide Catheter.

The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon

FDAOct 29, 2004Nationwide• Boston Scientific Scimed

Medtronic Xomed, Inc.: Brand name: NIM EMG Endotracheal Tube ...

The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.

FDAOct 29, 2004Nationwide• Medtronic Xomed, Inc.

Kyocera Cell Phone Batteries (Hecmma Group) – Battery Safety Issue (2004)

The recalled batteries are included in Kyocera Slider, K400, and 3200 Series cell phones. Below is additional information about the cell phones and recalled batteries: Cell Phone Model Name Cell Phone Model Number Battery Model Numbers Battery Description Slider Series SE44/SE47 CV90-L305N-01 CV90-L305P-01 CV90-L305T-01 CV90-L349T-01 Battery has the Kyocera name printed in red and black along with the model number K400 Series "Phantom" "Blade" "Rave" KE413 KE433 KE/KX414 KE/KX424 KE/KX434 CV90-K3040-03 CV90-K3040-09 CV90-K3040-10 CV90-K3040-11 Battery has the Kyocera name printed in red and white along with the model number 3200 Series 3225 3250 (Appears above or below phone display) CV90-K3040-03 CV90-K3040-09 CV90-K3040-10 CV90-K3040-11 Battery has the Kyocera name printed in red and white along with the model number

CPSCOct 28, 2004Nationwide• Hecmma Group, of El Paso, Texas

SCC Soft Computer: Product is SoftPath ASCII Software Releases 2.3.0 and 4.3...

Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.

FDAOct 27, 2004Nationwide• SCC Soft Computer

Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085: V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket...

The dispenser box was mislabeled with the wrong length and the wrong wire gauge.

FDAOct 27, 2004MS, MO, NY +4 more• Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085

Beckman Coulter Inc: SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classifi...

Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.

FDAOct 25, 2004Nationwide• Beckman Coulter Inc

Becton Dickinson & Company: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Nee...

Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

FDAOct 22, 2004AR, TX• Becton Dickinson & Company