State

South Carolina product recalls

72,820 recalls have nationwide distribution and so reach South Carolina. 7,114 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total: 7,114
Critical: 1,267
Severe: 1,869
Most recent: 2026-09-02

Of the 7,114 recalls naming South Carolina we have scored against our rubric, 1,267 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,869 (26%) are Severe.

Which agencies issued them

These figures cover only the 7,114 recalls whose distribution notice names South Carolina specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

376–400 of 79934

HighFDA (Devices)·Z-2837-2026·2026-08-12
Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips
Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.
Product
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2848-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks
The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2858-2026·2026-08-12
Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.
Product
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2864-2026·2026-08-12
Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2841-2026·2026-08-12
Powered wheelchair controller recalled for unexpected braking hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum 4Front 2 wheelchair controllers because reminder pop-ups can trigger unexpected park brake stops while driving, causing falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2898-2026·2026-08-12
United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E056000·2026-08-12
Odyne Recalls Hybrid Systems Due to Traction Battery Fire Risk
Odyne Systems is recalling certain hybrid systems with specific part numbers because the high-voltage batteries may fail, increasing the risk of a fire.
Product
ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2866-2026·2026-08-12
Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2851-2026·2026-08-12
Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues
A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2887-2026·2026-08-12
HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.
Product
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2893-2026·2026-08-12
Philips Fluoroscopy System Recall Over Hard Disk Drive Issue
Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2865-2026·2026-08-12
Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2878-2026·2026-08-12
GE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability
GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.
Product
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2846-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall
Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.
Product
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2883-2026·2026-08-12
Knee Prosthesis Trial Recall for Manufacturing Defect
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
Product
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2906-2026·2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2911-2026·2026-08-12
Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2026·2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2888-2026·2026-08-12
MicroScan LabPro V5.03 Panel Update 11 analyzers recalled for incorrect algorithms affecting test results
The FDA is recalling MicroScan LabPro V5.03 Panel Update 11 electronic analyzers because their algorithms may produce inaccurate antimicrobial susceptibility test results.
Product
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2899-2026·2026-08-12
GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
Product
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium h
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2861-2026·2026-08-12
DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chai
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2902-2026·2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2860-2026·2026-08-12
Flow Anesthesia Machines Recalled for Failure to Deliver Anesthetic Agent
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
Product
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2882-2026·2026-08-12
Happiest Baby Recalls Pre-Loved SNOO Smart Sleeper Bassinets
Happiest Baby, Inc is recalling 4 refurbished SNOO Smart Sleeper bassinets (Model S1000) that failed to meet quality standards before distribution. The recall is being reported retroactively.
Product
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0733-2026·2026-08-12
Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules
Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.
Product
DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide