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Outset Medical, Inc.

Outset Medical, Inc. Recalls

All product recalls associated with Outset Medical, Inc..

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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 3101–3120 of 37665 recalls

Tablo Console (Outset Medical) – Blood Leak Sensor Sensitivity (2024)

Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

High

FDAAug 1, 2024AL, AK, AZ +43 more• Outset Medical, Inc.

WallFlex Esophageal FC 18/23-25mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex PC Esoph Stent 18/23mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

SAF-T-LINER C2 (Thomas Built) – Ground Cable Problem (2024)

Fire/Burn Risk

Daimler Trucks North America, LLC (DTNA) is recalling certain Thomas Built Buses 2025 Saf-T-Liner C2 transit buses. The ground cable for the air conditioning system may have been improperly installed and overheat.

High

NHTSAAug 1, 2024Nationwide• THOMAS BUILT BUSES

WallFlex ESO Stent 23x105mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Cornerstone (Entegra) – Battery Cable Issue (2024)

Fire/Burn Risk

Jayco, Inc. (Jayco) is recalling certain 2024-2025 Entegra Anthem, Aspire, Cornerstone, Reatta, and Reatta XL motorhomes. The battery cables may not be the correct size, in the correct location, or they may be improperly tightened, which can cause an electrical short or allow the cables to overheat.

High

NHTSAAug 1, 2024Nationwide• ENTEGRA

Bikano Moong Dal (Thal Golden Spices) – salmonella risk (2024)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDAAug 1, 2024CA, IN• Thal Golden Spices Inc.

Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class IHigh

FDAAug 1, 2024Nationwide• Baxter Healthcare Corporation

J-Basket Napa Kimchi (JFC International) – yeast growth (2024)

High levels of Yeast growth and film on top of jarred Kimchi product.

Class IIModerate

FDAAug 1, 2024AZ, CO, FL +7 more• J F C International Inc

WallFlex ESO Stent LL 18x103 (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 12.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Low

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

MiniMed 630G (Medtronic) – Physical Impact Damage (2024)

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

High

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Lunds & Byerlys Smokin' Guacamole (Metro Produce) – listeria (2024)

Listeria

Guacamole products may be contaminated with Listeria monocytogenes.

Class IHigh

FDAJul 31, 2024MN• Metro Produce Distributors, Inc.

Cornerstone (Entegra) – Battery Overcurrent Protection (2024)

Fire/Burn Risk

Jayco, Inc. (Jayco) is recalling certain 2025 Entegra Cornerstone motorhomes. The chassis batteries could have inadequate overcurrent fuse protection.

Moderate

NHTSAJul 31, 2024Nationwide• ENTEGRA