Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Medtronic Perfusion Systems

Medtronic Perfusion Systems Recalls

All product recalls associated with Medtronic Perfusion Systems.

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

353

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 441–460 of 3680 recalls

Medtronic DLP Aortic Root Cannula (Medtronic) – Potential Sterility Breach (2024)

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Moderate

FDAOct 3, 2024IL, MI, NJ +4 more• Medtronic Perfusion Systems

Western Star 49X (WESTERN STAR) – Fuel Pump Delivery Issue (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2025 Freightliner Cascadia, Western Star 49X, Freightliner Custom Chassis XCM and Freightliner Custom Chassis XCP vehicles equipped with certain Cummins fuel pumps. The fuel pump barrels may fracture and cause a fuel leak, which can result in an engine stall.

High

NHTSAOct 1, 2024Nationwide• WESTERN STAR

King LTSD Size 2 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

1...21 222324 25...184

Page 23 of 184Next

FDA

Sep 26, 2024

Nationwide

• King Systems Corp. dba Ambu, Inc.

King LTSD Size 1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)

Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

Moderate

FDASep 25, 2024AZ, CA, FL +8 more• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden

A1CNow+ HbA1c System (PTS Diagnostics) – Code Mismatch Problem (2024)

The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.

Moderate

FDASep 18, 2024Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Quantimetrix Urine Control Set (McKesson) – Packaging Temperature Risk (2024)

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.

Low

FDASep 17, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

IMAGEnet 6 Ophthalmic System (Topcon) – Probability Map Error (2024)

The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided

Moderate

FDASep 17, 2024Nationwide• Topcon Medical Systems, Inc.

Cartesion Prime PET-CT (Canon) – Reconstruction Software Problem (2024)

Laceration Risk

When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.

Moderate

FDASep 17, 2024AL, AZ, AR +15 more• Canon Medical System, USA, INC.

SONIALVISION G4 (Shimadzu) – Image Display Problem (2024)

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Triathlon Universal Baseplate (Howmedica) – Locking Tabs Issue (2024)

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

High

FDASep 4, 2024Nationwide• Howmedica Osteonics Corp.

Leica Biosystems Cryostat (Leica) – Flammable Spray Risk (2024)

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

High

FDASep 4, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Epikut S Plus CM Implant (SIN) – Diameter Labeling Error (2024)

Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.

High

FDASep 1, 2024CA, CO, FL +7 more• SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva

Monarch Inflation Device (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

High

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Melrose Injector (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

High

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.