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Olympus Corporation of the Americas

Olympus Corporation of the Americas Recalls

All product recalls associated with Olympus Corporation of the Americas.

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Recall Summary

Total Recalls

1000

Past Year

276

Class I (Serious)

242

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 621–640 of 4099 recalls

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

ZVU Functional GI Software (Diversatek) – revision mislabeling (2023)

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

FDAJul 25, 2023Nationwide• Diversatek Healthcare

O-arm O2 Imaging System (Medtronic) – ground cable problem (2023)

Ground cable installed incorrectly.

FDAJul 25, 2023Nationwide• Medtronic Navigation, Inc.-Littleton

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Visera Hysterovideoscope (Olympus) – Labeling Update (2023)

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

FDAJul 20, 2023Nationwide• Olympus Corporation of the Americas

Freedom Boom Models (IHB) – Suspension Arm Weakness (2023)

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

FDAJul 19, 2023AL, AZ, AR +33 more• IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands

Randox Liquid Protein Calibrator (Randox) – Ferritin Restandardization (2023)

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

FDAJul 19, 2023CA, FL, IL +6 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

RayCare Software (RaySearch) – Allergy Warning Issue (2023)

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

FDAJul 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

ACL TOP Family Analyzer (Instrumentation Lab) – Result Misidentification (2023)

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

FDAJul 13, 2023Nationwide• Instrumentation Laboratory

Gas-Fired Hot Water Boilers (ECR International) – Carbon monoxide risk (2023)

Fire/Burn Risk

This recall involves gas-fired hot water residential boilers with brand names Dunkirk, Utica Boilers, Utica Heating, Pennco, Green Mountain and Columbia and with model numbers DXL-K, MGB-K, UH15B-K, 15B-K, GMGW-K, or MCB-K respectively. The boilers are blue and/or gray in color, 32 inches tall, 13 to 27 inches wide and 26 inches deep. The model and serial numbers are located on the boiler rating plate in the front left corner of the top panel. The following models and serial numbers are included in the recall: Brand Name Boiler Model Number Serial Number Range Dunkirk DXL-K: DXL-060K DXL-095K DXL-120K DXL-150K DXL-175K DXL-205K DXL-235K Serial Number Range: 392201652s thru 402202738s 012302567s and 012302571s Utica Boilers MGB-K: MGB-060K MGB-095K MGB-120K MGB-150K MGB-175K MGB-205K MGB-235K Serial Number Range: 402200481s thru 402202693s 012302268s thru 012302566s Columbia MCB-K: MCB-060K MCB-095K MCB-120K MCB-150K MCB-175K MCB-235K Serial Number Range: 402201449s thru 402202214s Utica Heating UH15B-K: UH15B-060K UH15B-095K UH15B-120K UH15B-150K UH15B-175K UH15B-235K Serial Number Range: 392201654s thru 402202800s 012302274s thru 012303099s Pennco 15B-K: 15B-060K 15B-095K 15B-120K 15B-150K 15B-175K 15B-235K Serial Number Range: 392202597s thru 402202806s 012301918s thru 012303055s Green Mountain GMGW-K: GMGW-060K GMGW-095K GMGW-120K GMGW-150K GMGW-175K GMGW-235K Serial Number Range: 392201653s thru 402202686s 012301924s thru 012301961s

CPSCJul 13, 2023Nationwide• ECR International Inc., of Utica, New York

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

Air/Water Valve (Olympus) – Valve Functionality Loss (2023)

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

Big J Unbleached Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Golden Loaf Bakers Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Trisodium Citrate Dihydrate (Cargill) – Metal contamination (2023)

Potential for foreign material (metal).

Class IIModerate

FDAJun 23, 2023AZ, CA, DE +11 more• Cargill, Inc Corporate Headquarters

Tripotassium Citrate (Cargill) – Metal Contamination (2023)

Potential for foreign material (metal).

Class IIModerate

FDAJun 23, 2023AZ, CA, DE +11 more• Cargill, Inc Corporate Headquarters

Iron Dietary Supplements (Prodigy) – Packaging issue (2023)

This recall involves Ferrous Sulfate Enteric-Coated Tablets dietary supplements containing 324 mg of ferrous sulfate (iron) in bottles of 100 tablets. "Nationwide Pharmaceutical" and its logo are printed on the top left of the bottle's label panel. The recalled bottles include lot numbers M0786, M0816, M0817 and M0818, which are printed on the bottom of the bottle.

CPSCJun 22, 2023Nationwide• Prodigy Innovation LLC, of Princeton, New Jersey

Liquid Urine Control (Randox) – Test Result Variation (2023)

(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.

FDAJun 21, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Level-1 Protein (1st Phorm) – Bacterial contamination (2023)

Product may contain Staphylococcus aureus.

Class IIModerate

FDAJun 21, 2023MO• International Food Companies DBA International Food Products

Tizanidine 4mg Tablets (Dr Reddy's) – Dissolution Specification (2023)

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Class IIModerate

FDAJun 21, 2023Nationwide• Dr Reddy's Laboratories Limited

ProPlan CMF Guide (Materialise) – Incorrect Guide Versions (2023)

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

FDAJun 19, 2023Nationwide• Materialise N.V. Technologielaan 15 Heverlee Belgium