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Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

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Recall Summary

Total Recalls

1000

Past Year

891

Class I (Serious)

124

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 3201–3220 of 17593 recalls

Medtronic Grafton Matrix Strips (Medtronic) – Packaging Concern (2023)

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Low

FDAFeb 8, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Grafton Plus Paste (Medtronic) – Packaging Concern (2023)

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Low

FDAFeb 8, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Grafton DBF (Medtronic) – Packaging Concern (2023)

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Low

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FDA

Feb 8, 2023

Nationwide

• Medtronic Sofamor Danek USA Inc

Fabuloso Multi-Purpose Cleaners (Colgate-Palmolive) – bacterial risk (2023)

This recall involves certain Fabuloso Multi-Purpose Cleaners, which is a multi-purpose cleaner that can be used to clean most residential hard surfaces. The first 8 digits of the lot code of the recalled products are 2348US78 through 2365US78 and 3001US78 through 3023US78. A list of the UPC and lot codes of the recalled products can be found at www.Fabulosorecall.com. For a complete list of products, visit www.Fabulosorecall.com. The lot code is located on the back of the bottle above the label either directly above or towards the top of the bottle. No Fabuloso Antibacterial variants or other Fabuloso products are impacted by this recall. The following Fabuloso Multi-Purpose Cleaners are included in this recall. Lavender Scent Fabuloso Original Multi-Purpose Cleaner, Lavender Scent, 22 FL OZ Fabuloso Multi-Purpose Cleaner 2X Concentrated Formula, Lavender Scent, 56 FL OZ, 128 FL OZ, 169 FL OZ Fabuloso Multi-Purpose Cleaner, Lavender Scent, 210 FL OZ Fabuloso Professional All Purpose Cleaner & Degreaser, Lavender Scent, 1 GALLON Refreshing Lemon Scent Fabuloso Original Multi-Purpose Cleaner, Refreshing Lemon Scent, 22 FL OZ Fabuloso Multi-Purpose Cleaner 2X Concentrated Formula, Refreshing Lemon Scent, 33.8 FL OZ, 56 FL OZ, 128 FL OZ and 169 FL OZ Passion of Fruits Scent Fabuloso Multi-Purpose Cleaner 2X Concentrated Formula, Passion of Fruits Scent, 33.8 FL OZ, 56 FL OZ, 128 FL OZ and 169 FL OZ Spring Fresh Scent Fabuloso Multi-Purpose Cleaner Bleach Alternative 2X Concentrated Formula, Spring Fresh Scent, 56 FL OZ Ocean Scent Fabuloso Professional All Purpose Cleaner & Degreaser, Ocean Scent, 1 GALLON

Moderate

CPSCFeb 8, 2023Nationwide• Colgate-Palmolive Company, of New York

Medtronic Grafton Flex (Medtronic) – Packaging Concern (2023)

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Low

FDAFeb 8, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Can-Am Spyder F3-S (Can-Am) – Mirror Lens Detachment (2023)

Bombardier Recreational Products Inc. (BRP) is recalling certain 2022 Cam-Am Spyder F3 and F3-S motorcycles. The rearview mirror lens may detach from the housing.

Low

NHTSAFeb 5, 2023Nationwide• CAN-AM

Cayenne Pepper (Tampico Spice) – Aflatoxin Contamination (2023)

Product was found to have an elevated amount of Aflatoxin

Class IIModerate

FDAFeb 2, 2023AZ, CA, NV +5 more• Tampico Spice Company Inc

Cajun Seasoning (Tampico Spice) – Aflatoxin Contamination (2023)

Product was found to have an elevated amount of Aflatoxin

Class IIModerate

FDAFeb 2, 2023AZ, CA, NV +5 more• Tampico Spice Company Inc

Taco Meat Seasoning (Tampico Spice) – Aflatoxin Contamination (2023)

Product was found to have an elevated amount of Aflatoxin

Class IIModerate

FDAFeb 2, 2023AZ, CA, NV +5 more• Tampico Spice Company Inc

BD Ultra-Fine Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

High

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

Heartsine Samaritan PAD (HeartSine) – Language Configuration (2023)

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

High

FDAFeb 1, 2023AZ, AR, CA +5 more• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

BD Ultra-Fine II Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

High

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

BD Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

High

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

Posaconazole Tablets (Biocon Pharma) – High Impurities (2023)

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Class IIModerate

FDAJan 31, 2023Nationwide• BIOCON PHARMA INC

DRX-Compass X-ray System (Carestream) – Tube Movement (2023)

After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury

High

FDAJan 30, 2023Nationwide• Carestream Health, Inc.

Delsam Artificial Tears (Global Pharma) – CGMP Deviation (2023)

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Artificial Tears Eye Drops (Global Pharma) – Bacterial Contamination (2023)

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Class IHigh

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Artificial Tears Eye Drops (Global Pharma) – CGMP Deviation (2023)

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Delsam Artificial Tears (Global Pharma) – Bacterial Contamination (2023)

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Class IHigh

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Access Immunoassay Systems (Beckman Coulter) – Nut Band Damage (2023)

An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.

Moderate

FDAJan 26, 2023Nationwide• Beckman Coulter, Inc.