State

Kentucky product recalls

72,913 recalls have nationwide distribution and so reach Kentucky. 7,164 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total: 7,164
Critical: 1,399
Severe: 1,694
Most recent: 2026-09-09

Of the 7,164 recalls naming Kentucky we have scored against our rubric, 1,399 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,694 (24%) are Severe.

Which agencies issued them

These figures cover only the 7,164 recalls whose distribution notice names Kentucky specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2101–2125 of 80077

ModerateFDA (Drugs)·D-0507-2026·2026-05-06
Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1945-2026·2026-05-06
Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
Product
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device desig
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1958-2026·2026-05-06
Philips Ingenia 3.0T MRI System with Elastography Software Recall
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Product
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1956-2026·2026-05-06
Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall
Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.
Product
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2026·2026-05-06
Genius Review Station Display Modified Outside Validated Configuration
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Product
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.
Product
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1988-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0685-2026·2026-05-06
Calypso Tropic Tango Lemonade contains undeclared Yellow No. 5
Calypso Tropic Tango Lemonade is being recalled because it contains undeclared Yellow No. 5. The action covers 299,779 cases distributed nationwide and to four other markets.
Product
Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2026·2026-05-06
Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.
Product
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1946-2026·2026-05-06
Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
Product
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2026·2026-05-06
Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Product
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0505-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.
Product
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2002-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Product
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1950-2026·2026-05-06
HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance
Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.
Product
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2003-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
Product
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1964-2026·2026-05-06
Philips MR 7700 MR Elastography device stiffness value error recall
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
Product
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2026·2026-05-06
Philips Ingenia Elition S MRI stiffness value error correction
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
Product
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2026·2026-05-06
Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Product
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2026·2026-05-06
Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.
Product
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1985-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Category
Drug
Distribution
Distributed nationwide