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Synthes (USA) Products LLC

Synthes (USA) Products LLC Recalls

All product recalls associated with Synthes (USA) Products LLC.

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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 4381–4400 of 37665 recalls

VA-LCP Clavicle Plate (Synthes) – Sterilization Uncertainty (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

TFNA Femoral Nail 11mm (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Moderate

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Page 220 of 1884Next

FDA

Jan 24, 2024

Nationwide

• Siemens Healthcare Diagnostics, Inc.

RIA Tube Assembly (Synthes) – Sterilization Uncertainty (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

2.5mm Drill Bit (Synthes) – Sterilization Uncertainty (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

Titanium Hindfoot Nail (Synthes) – Sterilization Uncertainty (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

1.5MM Drill Bit (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

CVS Health Wound Tracking Dressing (Medline) – Failed Sterility Test (2024)

Product failed sterility testing.

High

FDAJan 23, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Norepinephrine Injection (Baxter) – Label Concentration Error (2024)

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

Class IIModerate

FDAJan 23, 2024Nationwide• Baxter Healthcare Corporation

Golden Owl Dried Mango – undeclared sulfites (2024)

Undeclared Allergen

Undeclared sulfites

Class IHigh

FDAJan 23, 2024FL, GA, IL +14 more• TRUONG GIANG WAREHOUSE

Tesla Model S (Tesla) – Camera Sensing System (2024)

Tesla, Inc. (Tesla) is recalling certain 2023 Model S, X, and Y vehicles equipped with full self-driving computer 4.0 and running a software release version 2023.44.30 through 2023.44.30.6 or 2023.44.100. Software instability may prevent the rearview camera image from displaying.

High

NHTSAJan 22, 2024Nationwide• TESLA

Duet External Drainage System (Medtronic) – Catheter Disconnection Risk (2024)

Potential for catheter disconnection from the patient line stopcock connectors.

High

FDAJan 22, 2024Nationwide• Medtronic Neurosurgery

Tensive Conductive Adhesive Gel (Parker) – Viscosity Complaint (2024)

Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

Low

FDAJan 22, 2024AZ, CA, FL +7 more• Parker Laboratories, Inc.

Battery Mobile X-ray Unit (Sedecal) – Anti-Fall System Interference (2024)

Potential interference with the anti-fall system.

Moderate

FDAJan 22, 2024Nationwide• SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain

BiMobile Dual Mobility System (Waldemar Link) – Mislabeling Risk (2024)

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

Low

FDAJan 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Vasopressin Injection (IntegraDose) – Sub-potent Drug (2024)

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Class IIModerate

FDAJan 22, 2024MN• IntegraDose Compounding Services LLC

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

High

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

High

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

High

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

High

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.