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Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

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Recall Summary

Total Recalls

1000

Past Year

726

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 4461–4480 of 11124 recalls

Access Immunoassay Systems (Beckman) – Biotin Interference (2019)

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

Moderate

FDAApr 30, 2019AL, AK, AZ +47 more• Beckman Coulter Inc.

Endotrac ECTR Kit (Stryker) – Sterile Bag Integrity (2019)

The seal integrity of the sterile bag containing the kits may be compromised.

Low

FDAApr 30, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

DEXIS Titanium Sensor (KaVo) – Image Quality Reduction (2019)

The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.

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Low

FDAApr 29, 2019Nationwide• KaVo Dental Technologies LLC

Aquarius D13S319 Probe (Cytocell) – Chromomap Error (2019)

There is an error in the chromomap on the package insert.

Low

FDAApr 26, 2019Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Zenith Alpha Graft (Cook) – Safety Lock Knob Damage (2019)

may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.

Moderate

FDAApr 26, 2019Nationwide• Cook Inc.

Sagittal Saw Attachment (Mako) – Ungreased Bearings (2019)

The bearings of the saw attachments were ungreased.

Low

FDAApr 25, 2019AR, CA, FL +10 more• Mako Surgical Corporation

Vitodens Boilers (Viessmann) – carbon monoxide hazard (2019)

This recall involves the Vitodens 200-W and Vitodens 222-F series boilers used for space or domestic water heating. There are five affected models in a specific serial number range. The Vitodens 200-W is a wall hung unit, housed in a white metal box about 38 inches high and 18 inches wide. The Vitodens 222-F is a floor mounted unit, housed in a white metal box about 68 inches tall and 24 inches wide. The name "Vitodens" is printed on the label on the outside of the boiler box. The product name and model number can be found on the left side of the boiler cover. The serial number can be found on the underside of the wall mounted boiler and on the center section on the floor mount model. Product Model Part Number Serial Number Range Vitodens 200-W B2HB 19 7538092 7538092401003107 to 7538092701038106 B2HB 26 7538093 7538093401002107 to 7538093701177109 B2HB 35 7538094 7538094401003101 to 7538094701446103 Vitodens 222-F B2TB 19 7542250 7542250401001100 to 7542250401210106 B2TB 35 7542251 7542251401001107 to 7542251701257105

Very High

CPSCApr 25, 2019Nationwide• Viessmann Werke GmbH & Co KG, of Germany

Sagittal Saw Attachment (Mako) – Ungreased Bearings (2019)

The bearings of the saw attachments were ungreased.

Low

FDAApr 25, 2019AR, CA, FL +10 more• Mako Surgical Corporation

Losartan Potassium Tablets (Legacy) – NMBA Impurity (2019)

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Class IIModerate

FDAApr 24, 2019AZ, TN• Legacy Pharmaceutical Packaging LLC

Cilantro Lime Green Sauce (Wegmans) – foreign material (2019)

Product may contain foreign material

Class IIModerate

FDAApr 24, 2019MD, MA, NJ +3 more• Wegmans Food Markets, Inc.

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide• AVKARE Inc.

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide• AVKARE Inc.

Flexible Intubation Fiberscope 11301AB1 (Karl Storz) – Manufacturing Error (2019)

The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

High

FDAApr 24, 2019CA, CO, LA +6 more• Karl Storz Endoscopy

Fentanyl Citrate Injection (Akorn Inc) – Impurity Specification (2019)

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

Class IIILow

FDAApr 23, 2019Nationwide• Akorn Inc

Connected OR Cart 120V (Stryker) – Monitor Attachment Issue (2019)

There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.

Moderate

FDAApr 23, 2019Nationwide• Stryker Corporation

Stove Top Espresso Makers (Bodum) – fire and burn hazard (2019)

Fire/Burn Risk

This recall involves CHAMBORD® stove top espresso makers in a stainless steel finish. The recall includes 6-cup (12 ounce) espresso makers with SKU number 10617-16. This SKU number appears on the packaging of the product. The word "Bodum" is embossed on the lower half of the product.

High

CPSCApr 23, 2019Nationwide• Kimcoland (Zhejiang Goldsen) Industry and Trade Co. Ltd., of China

Abalone in Brown Sauce (Haiku) – undeclared oyster sauce (2019)

Undeclared Allergen

Product contains undeclared Oyster Sauce

Class IIILow

FDAApr 23, 2019CA, IN• Haiku(Us) Mr Ocean Seafood Corp.

Cook Salle Intraoperative Pyeloplasty Stent Set (Cook) – Instructions Omission (2019)

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

Moderate

FDAApr 22, 2019Nationwide• Cook Inc.

Cook Kwart Retro-Inject Ureteral Stent Set (Cook) – Instructions Omission (2019)

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

Moderate

FDAApr 22, 2019Nationwide• Cook Inc.

Losartan Potassium/HCTZ Tablet (RemedyRepack) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 22, 2019FL• RemedyRepack Inc.