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Smiths Medical ASD Inc.

Smiths Medical ASD Inc. Recalls

All product recalls associated with Smiths Medical ASD 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 2141–2160 of 21320 recalls

BLUperc Procedural Tray (Smiths Medical) - Balloon Disconnection (2024)

There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.

High

FDAJun 7, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical Portex BLUgriggs Trays (Smiths Medical) – Pilot Balloon Disconnect (2024)

High

FDAJun 7, 2024Nationwide• Smiths Medical ASD Inc.

Red Button Vintage Cookie Dough Ice Cream (Casper's) – Foreign Object (2024)

Foreign object, rubber, found in two tubs of Red Button Vintage Creamery Cookie Dough Ice Cream.

Class II

1...106 107108109 110...1066

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Moderate

FDAJun 6, 2024AZ, CO, ID +5 more• Casper's Ice Cream, Inc

Arepas La Mejor Chocolate Sweet Corn (Villa Nueva) – Milk Allergen (2024)

Undeclared Allergen

Undeclared allergens: Milk

Class IHigh

FDAJun 6, 2024FL• Villa Nueva Interservices LLC

Philips SENSE XL Torso Coil (Philips) – Patient Burn Risk (2024)

Fire/Burn Risk

Potential for coils to heat up and harm patients (burn).

Moderate

FDAJun 5, 2024Nationwide• Philips North America Llc

Philips SENSE XL Torso Coil Mk2 (Philips) – Patient Burn Risk (2024)

Fire/Burn Risk

Potential for coils to heat up and harm patients (burn).

High

FDAJun 5, 2024Nationwide• Philips North America Llc

Synergetics I Pack Injection Kit (MICROspecialties) – Sterilization Concern (2024)

Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

High

FDAJun 5, 2024MO• MICROspecialties, Inc.

Philips SENSE XL Torso Coil (Philips) – Patient Burn Risk (2024)

Fire/Burn Risk

Potential for coils to heat up and harm patients (burn).

High

FDAJun 5, 2024Nationwide• Philips North America Llc

Zyno Medical Infusion Pumps (Zyno Medical) – Power Supply Failure (2024)

Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.

Moderate

FDAJun 4, 2024Nationwide• Zyno Medical LLC

Meridian Angled Awl (SeaSpine) – Insufficient Weld (2024)

Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

Moderate

FDAJun 4, 2024AZ, CA, CO +15 more• SEASPINE ORTHOPEDICS CORPORATION

Amoxicillin Chewable Tablets (Teva) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJun 4, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Bag Decanter II (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Moderate

FDAJun 3, 2024Nationwide• Microtek Medical Inc.

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

C-Flow Bag Decanter (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Moderate

FDAJun 3, 2024Nationwide• Microtek Medical Inc.

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Nalu Neurostimulation Kit (Nalu Medical) – Signal Efficiency Problem (2024)

Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

High

FDAJun 3, 2024Nationwide• Nalu Medical, Inc.