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EMPATICA SRL Via Enrico Stendhal

EMPATICA SRL Via Enrico Stendhal Recalls

All product recalls associated with EMPATICA SRL Via Enrico Stendhal.

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Recall Summary

Total Recalls

1000

Past Year

304

Class I (Serious)

Most Recent

Nov 2025

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 681–700 of 4747 recalls

Embrace2 Device (Empatica) – Battery Life Limitation (2023)

May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

FDAJul 13, 2023Nationwide• EMPATICA SRL Via Enrico Stendhal

Methylphenidate Tablets (Sun Pharmaceutical) – foreign substance (2023)

Presence of Foreign Substance: Metal embedded in a tablet.

Class IIModerate

FDAJul 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

1...33 343536 37...238

Page 35 of 238Next

FDA

Jul 11, 2023

Nationwide

• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH HDL Cholesterol- In vitro diagnostic use in ... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from AtellicaCH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Loteprednol Eye Suspension (Sun Pharma) – Potency Issue (2023)

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Class IIILow

FDAJul 5, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sunitinib Capsules (Teva) – Moisture Limit Failure (2023)

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Class IIModerate

FDAJul 5, 2023Nationwide• Teva Pharmaceuticals USA Inc

Amlodipine Tablets (Lupin) – Potency Failure (2023)

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Class IIILow

FDAJun 27, 2023Nationwide• Lupin Pharmaceuticals Inc.

Tizanidine Hydrochloride Tablet 4mg (Preferred Pharmaceuticals) – Stability Failure (2023)

Failed Stability Specifications

Class IIModerate

FDAJun 26, 2023Nationwide• Preferred Pharmaceuticals, Inc.

UroLift Visual Obturator (Scholly Fiberoptic) – Weld Defect (2023)

There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

FDAJun 23, 2023Nationwide• Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany

Tydemy Birth Control Tablets (Lupin) – Impurity Specification Failure (2023)

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Class IHigh

FDAJun 23, 2023Nationwide• Lupin Pharmaceuticals Inc.

Concord Dual Power Recliner Chairs (Havertys) – Fall hazard (2023)

This recall involves Havertys Concord Dual Power Recliner chairs with SKU 0-3500-1827 that is printed on a label affixed to the chair. The chairs are upholstered with leather in a variety of colors including blue and brown. The chairs measure 33 inches wide by 41.5 inches deep by 39.5 inches high. Havertys' label is located under the seat cushion.

CPSCJun 22, 2023Nationwide• Artistic Leathers S de RL de CV, of Mexico (Chairs)