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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

730

Class I (Serious)

175

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 1701–1720 of 11124 recalls

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

Incorrect Laser Marking - Solera Awl Tip Tap

Low

FDAJul 12, 2023Nationwide• Medtronic Sofamor Danek USA, Inc

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

Lipemic interference failed to meet the performance specification listed within the IFU.

Moderate

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.

SurgiCount+ Software Application-indicated as an adjuncti... (Stryker Corporation) – potential for current software to mis... (2023)

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Low

FDA

1...84 858687 88...557

Page 86 of 557Next

Jul 10, 2023

Nationwide

• Stryker Corporation

Five S 5 3x65, REF: 0915612-06, sterile for single use, S... (Karl Storz Endoscopy) – flexible intubation endoscopes steri... (2023)

Flexible intubation endoscopes sterility assurance can not be confirmed.

High

FDAJul 7, 2023Nationwide• Karl Storz Endoscopy

woom ORIGINAL Bicycles (woom Bikes) – Fall risk (2023)

This recall involves all sizes of woom ORIGINAL 2018 - 2021 model bikes. The stems on these bikes have one silver bolt to clamp onto the steerer tube. These bikes are designed for children between 18 months and 14 years. They were sold in six versions: woom 1, woom 1 Plus, woom 2, woom 3, woom 4, woom 5 and woom 6. The woom 1 and woom 1 PLUS are balance bikes, woom 2 through 6 are pedal bikes. These bikes were sold in red, green, blue, purple and yellow colors. The word "woom" in white letters is displayed on the sides of the downtube. The word "woom" in metallic letters is also visible on the front of the headtube. The markings "#woombikes" in black letters on chain stay and wheel size in black on sides of the front fork.

High

CPSCJul 6, 2023Nationwide• woom Bikes USA, of Austin, Texas

Access Thyroglobulin Calibrators (Beckman Coulter, Inc.) – it has been determined through an int... (2023)

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

Low

FDAJul 6, 2023Nationwide• Beckman Coulter, Inc.

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Moderate

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

Moderate

FDAJun 28, 2023Nationwide• Stryker Corporation

2019 KIDRON REFRIGERATED BODIES – fire hazard (2023)

Fire/Burn Risk

ST Engineering Hackney, Inc. (STE Hackney) is recalling certain 2011-2021 Kidron refrigerated truck bodies equipped with certain Carrier Transicold refrigeration units, including Supra models 950, 950MT, and 960. The centrifugal clutch may overheat under certain conditions, which can cause it to break apart.

High

NHTSAJun 28, 2023Nationwide• KIDRON

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) ... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).

Moderate

FDAJun 28, 2023Nationwide• Stryker Corporation

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-53... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

Moderate

FDAJun 28, 2023Nationwide• Stryker Corporation

Ecolab Banded Bag (Microtek Medical) – Naphthalene Odor (2023)

Certain lots of the products have a Naphthalene odor.

Moderate

FDAJun 23, 2023Nationwide• Microtek Medical Inc.

Equipment and Table Drapes (Microtek Medical) – Naphthalene Odor (2023)

Certain lots of the products have a Naphthalene odor.

Moderate

FDAJun 23, 2023Nationwide• Microtek Medical Inc.

Safe Tussin DM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Safe Tussin PM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Fusion Lithotripsy Basket (Wilson-Cook) – Product Non-Conformance (2023)

Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

High

FDAJun 22, 2023Nationwide• Wilson-Cook Medical Inc.

Gore Tips Set Device (Creganna Medical) – Incorrect Expiration Label (2023)

Three lots of product may be labeled with an incorrect expiration day

Moderate

FDAJun 22, 2023Nationwide• Creganna Medical Devices Parkmore House Mweeloon Galway Ireland

HoverMatt (Stryker) – Incorrect Mattress Dimensions (2023)

39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.

Moderate

FDAJun 21, 2023AZ, CA, FL +8 more• Stryker Sustainability Solutions

VOLKSWAGEN GTI (Volkswagen) – Strut Mount Deformation (2023)

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2023 Golf R A8 and Golf GTI vehicles. The strut mount may be deformed, loosening the bolted connections to the suspension strut mounting.

Moderate

NHTSAJun 21, 2023Nationwide• VOLKSWAGEN

VOLKSWAGEN ID.4 (Volkswagen) – Display Function Issue (2023)

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2022 ID.4 vehicles. The replacement infotainment central control unit (CCU) installed in the vehicle during a repair contains incorrect software that can cause the rearview camera image to be delayed or deactivated when reversing. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."

Moderate

NHTSAJun 21, 2023Nationwide• VOLKSWAGEN