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Bayer Healthcare Pharmaceuticals Inc.

Bayer Healthcare Pharmaceuticals Inc. Recalls

All product recalls associated with Bayer Healthcare Pharmaceuticals Inc..

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Recall Summary

Total Recalls

1000

Past Year

897

Class I (Serious)

124

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 2061–2080 of 17593 recalls

Vitrakvi Oral Solution (Bayer) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Class IHigh

FDANov 6, 2023Nationwide• Bayer Healthcare Pharmaceuticals Inc.

ENDOEYE HD II Videoscope (Olympus) – image coloration (2023)

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

Moderate

FDANov 6, 2023Nationwide• Olympus Corporation of the Americas

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

1...102 103104105 106...880

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Moderate

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Allura Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Adrenaline RV (Coachmen) – lighting issue (2023)

Forest River, Inc. (Forest River) is recalling certain 2018-2024 Coachmen Adrenaline and 2020-2024 Work and Play fifth wheels and travel trailers. The side marker lights may not reflect light as intended, which can make it difficult for other drivers to see the trailer. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

Low

NHTSANov 3, 2023Nationwide• COACHMEN

Quantum Biliary Balloon Dilator (Wilson-Cook) – device nonconformity (2023)

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

Moderate

FDANov 3, 2023Nationwide• Wilson-Cook Medical Inc.

Azurion Systems (Philips) – ceiling mount collision risk (2023)

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Le Croissant Chicken Salad (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IHigh

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Le Croissant Tuna Salad (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IHigh

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Le Croissant Turkey & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Breakfast Sandwich Bacon Egg & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Le Croissant Ham & Swiss (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared Milk

Undeclared milk and soy

Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Stratus Imaging PACS (Change Healthcare) – message association error (2023)

Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

High

FDANov 1, 2023Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Lubricating Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lubricating Tears Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Cosco Activity Center – fall hazard (2023)

This recall involves Cosco Jump, Spin & Play Activity Centers with model numbers WA105FZW and WA105GML. The activity centers have a circular hoop base and three poles from which a child seat with a play tray is suspended by three straps. The activity centers are sold in blue and pink, and feature two removable toy animals on the play tray at the front of the seat as well as two toy animals hanging from the front two poles. The activity centers can be adjusted to three different heights.

High

CPSCOct 26, 2023Nationwide• Dorel Juvenile Group Inc., of Columbus, Indiana

Bobcat Zero-Turn Lawnmowers – crash risk (2023)

Laceration Risk

This recall involves Bobcat-branded and Kubota-branded stand-on zero-turn lawnmowers. The Bobcat stand-on zero-turn lawnmowers are black and white with the Bobcat name and logo on an orange background. They also have orange wheel wells. The Kubota stand-on zero-turn lawnmowers are orange and black with the Kubota name in white and orange wheel wells. The following model and serial numbers, located on the right side of the frame just above the operator platform, are included in this recall. The recalled engines are model year 2023 FR730V, FR691V, and FR651V. The recalled engine model and serial numbers are located on the engine fan housing. The following model and serial number ranges are included in this recall. Bobcat: MODEL SERIAL NUMBER ZS4036 999400100961 thru 999400100973 999400100975 thru 999400101046 999400101049 thru 999400101053 999400101055 ZS4036 SJAU 9994001AU80157 thru 9994001AU80165 9994001AU80168 thru 9994001AU80169 ZS4048 999400201096 thru 999400201170 ZS4048 SFAU 9994002AU00141 thru 9994002AU00145 ZS4052 999400301247 thru 999400301380 999400301382 thru 999400301385 999400301387 thru 999400301397 ZS4052 SKAU 9994003AU00125 ZS4061 999400400750 thru 999400400822 999400400826 thru 999400400831 999400400833 thru 999400400834 999400400836 thru 999400400838 ZS4061 SKAU 9994004AU00111 thru 9994004AU00112 Kubota: MODEL SERIAL NUMBER SZ19NC-36-2 14490 thru 14517 14618 thru 14620 14678 thru 14679 14803 thru 14818 14835 thru 14850 14856 thru 14857 14922 thru 14927 15051 thru 15062 SZ22NC-48-2 14380 14401 thru 14412 14566 thru 14568 14666 thru 14677 14695 thru 14700 14706 thru 14711 14790 thru 14796 14858 thru 14869 14928 thru 14931 15030 thru 15044 SZ26NC-52-2 14429 thru 14446 14466 thru 14471 14474 14484 thru 14489 14577 thru 14609 14692 thru 14694 14701 thru 14705 14712 thru 14717 14780 thru 14783 14872 thru 14888 14892 14921 14944 thru 14967 14992 thru 15007 SZ26NC-61-2 14417 thru 14425 14475 thru 14483 14622 thru 14643 14718 14763 thru 14771 14893 thru 14904 14971 thru 14991 15014 thru 15026 SZ19-36-2CAD 14558 thru 14565, 14801 SZ22-48-2CAD 14569 thru 14576, 14870 thru 14871, 15045 SZ26-61-2CAD 15009 thru 15013, 15029 1698562

High

CPSCOct 26, 2023Nationwide• Doosan Bobcat North America, of West Fargo, North Dakota

Kawasaki Lawn Mower Engines – fire risk (2023)

Fire/Burn Risk

This recall involves Kawasaki engines used in riding lawn mowers sold under the Ariens brand name with mower models IKON, IKON Onyx, and Apex, and under the Gravely brand name with mower models ZT X, ZT XL, ZT HD, and ZT HD Stealth, and under the Husqvarna brand name with mower models TS142TXD, TS242TXD, TS242XD, Z248F, and Z254F, and under the John Deere brand name with mower models Z330M and Z330R, and under the RedMax brand name with mower model RZT48. The recalled engines are model year 2023 FR730V, FR691V, and FR651V. The recalled engine model and serial numbers are located on the engine fan housing. The following model and serial number ranges are included in this recall. Engine Model Number Specification Number FR651V GS28 FR691V GS19 ES29 FR730V FS15 Engine Serial Number Range A full list of serial numbers included in this recall are on the firm's website at www.kawasakienginesusa.com/product-recall.html recall notice RP230415.

High

CPSCOct 26, 2023Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A., of Maryville, Missouri

CD11b APC (BD Biosciences) – cell staining quality (2023)

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

High

FDAOct 25, 2023Nationwide• Becton, Dickinson and Company, BD Biosciences

INDICAID COVID-19 Test (Phase Scientific) – incorrect expiration (2023)

COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

Low

FDAOct 25, 2023Nationwide• PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR