State

Florida product recalls

73,478 recalls have nationwide distribution and so reach Florida. 12,862 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total: 12,862
Critical: 1,775
Severe: 3,455
Most recent: 2026-10-14

Of the 12,862 recalls naming Florida we have scored against our rubric, 1,775 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3,455 (27%) are Severe.

Which agencies issued them

These figures cover only the 12,862 recalls whose distribution notice names Florida specifically. The 73,478 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

21576–21600 of 86340

HighFDA (Devices)·Z-1724-2022·2022-09-21
ICU Medical Trifuse Extension Set Recalled for Connector Housing Gap
ICU Medical is recalling 5.8 million Trifuse Extension Sets due to a manufacturing defect that creates a visible gap between the connector's housing parts. The gap could lead to disconnection or fluid leakage during infusion.
Product
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1523-2022·2022-09-21
Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns
Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.
Product
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1528-2022·2022-09-21
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.
Product
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2022·2022-09-21
Sterile Dental Rolls Recalled: New Cotton Source Sterility Not Validated
Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.
Product
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1532-2022·2022-09-21
TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.
Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1525-2022·2022-09-21
FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance
Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.
Product
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1716-2022·2022-09-21
Roadrunner UniGlide wire guide recalled for potential sterility compromise
Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1517-2022·2022-09-21
Injectable drug product recalled for lack of sterility assurance
Carolina Infusion is recalling MIC/B12/L-Carn (HD) injectable vials due to inability to assure product sterility. The product was distributed nationwide.
Product
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2022·2022-09-21
Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1706-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise
Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2022·2022-09-21
Vascular Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1537-2022·2022-09-21
Hand Sanitizer Recalled for Manufacturing Defects and Chemical Impurities
Superior Glove Works is recalling Synergy Hand Sanitizer due to acetaldehyde impurity and excess total impurities above specification limits. The 80% alcohol topical antiseptic was distributed nationwide.
Product
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1717-2022·2022-09-21
Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1719-2022·2022-09-21
Medical connector recalled due to manufacturing housing gap defect
ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.
Product
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1520-2022·2022-09-21
Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue
Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.
Product
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2022·2022-09-21
Vascular wire guides recalled due to potential sterility compromise
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1515-2022·2022-09-21
L-Carnitine Injectable Recalled Due to Sterility Assurance Failure
Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.
Product
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1751-2022·2022-09-21
iSED Tubing Spare Part Recalled for Potential Biohazard Leak Risk
Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kits due to potential biohazard leak from the Probe Tube when installed on the iSED ESR Analyzer. Affected lot (4/22) includes 38 units distributed nationwide and internationally.
Product
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1521-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.
Product
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2022·2022-09-21
ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1526-2022·2022-09-21
Injectable Drug Recall: TRI-MIX 30/1/10 Vials Lack Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/10 injectable vials nationwide because the sterility of the product cannot be assured. This FDA Class II recall affects 16 vials distributed across multiple lots with expiration dates through October 2022.
Product
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2022·2022-09-21
GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear
Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2022·2022-09-21
Extension Set Recall Due to Connector Housing Manufacturing Defect
ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.
Product
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Category
Medical Device
Distribution
53 states