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American Spice LLC

American Spice LLC Recalls

All product recalls associated with American Spice LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

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 2201–2220 of 21320 recalls

Ground Cinnamon (Spice Class) – high lead levels (2024)

Product contains elevated levels of lead (2,040ppb).

Class IIModerate

FDAMay 28, 2024NY• American Spice LLC

PROBEAT-FR (Hitachi) – Image Matching Software Error (2024)

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

Low

FDAMay 27, 2024Nationwide• Hitachi America, Ltd., Particle Therapy Division

WOM Tube Set (WOM) – Transponder Data Error (2024)

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

Low

1...109 110111112 113...1066

Page 111 of 1066Next

FDA

May 24, 2024

Nationwide

• WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany

Suntegrity Sunscreen (Synchronicity) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Suntegrity Sunscreen (Synchronicity) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

Class IHigh

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Gray Revision Instrument Tray (Howmedica) – Case Design Issue (2024)

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

High

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

HRIS Storage Tray (Howmedica) – Case Design Problem (2024)

Low

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

High

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Avalon Ultrasound Transducer (Philips) – Fetal Measurement Error (2024)

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

High

FDAMay 22, 2024Nationwide• Philips North America Llc

Abbott Infinity 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

High

FDAMay 22, 2024Nationwide• Abbott Medical

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Moderate

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

Abbott Infinity 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

High

FDAMay 22, 2024Nationwide• Abbott Medical

IsoLoc Prostate Balloon (Angiodynamics) – Mislabeling Risk (2024)

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

Low

FDAMay 21, 2024Nationwide• Angiodynamics, Inc.

VITROS Chemistry Diluent Pack (Ortho-Clinical) – Sample Result Bias (2024)

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

Moderate

FDAMay 21, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

RAPIDPoint 500e Blood Gas System (Siemens) – Sample Source Identification (2024)

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

High

FDAMay 17, 2024Nationwide• Siemens Healthcare Diagnostics Inc

Stimuplex A 30 DEG 20GX6 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Stimuplex A 30 DEG 21GX4 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Stimuplex A 30 DEG 24GX1 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Fathom Pedicle-Based Retractor (SEASPINE) – Blade Fracture Risk (2024)

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

High

FDAMay 17, 2024Nationwide• SEASPINE ORTHOPEDICS CORPORATION

Stimuplex A 30 DEG 22GX2 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc