State

South Carolina product recalls

72,992 recalls have nationwide distribution and so reach South Carolina. 7,117 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total: 7,117
Critical: 1,268
Severe: 1,870
Most recent: 2026-09-16

Of the 7,117 recalls naming South Carolina we have scored against our rubric, 1,268 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,870 (26%) are Severe.

Which agencies issued them

These figures cover only the 7,117 recalls whose distribution notice names South Carolina specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8226–8250 of 80109

HighFDA (Devices)·Z-1038-2025·2025-02-05
Knee implant articular surface recalled for incorrect metal post assembly
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2025·2025-02-05
Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
Product
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2025·2025-02-05
Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
Product
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2025·2025-02-05
Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2025·2025-02-05
Medline procedure kits recalled for surgical masks failing sterilization tests
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2025·2025-02-05
AXIOS Stent Distal Tip Detachment Prevents Proper Expansion
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1056-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Product
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2025·2025-02-05
AXIOS Stent Delivery System recalled due to distal sheath detachment
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Product
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
Product
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2025·2025-02-05
Implantable VNS Therapy Generators May Stop Delivering Treatment
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Product
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2025·2025-02-05
HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath Detachment Recall (47 Units)
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2025·2025-02-05
Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Product
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0212-2025·2025-02-05
Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1021-2025·2025-02-05
Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
Product
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2025·2025-02-05
Bedside cardiac monitor system recalled for display distortion
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0213-2025·2025-02-05
Prescription Drug Inflectra Recalled Nationwide for Manufacturing Quality Deviations
McKesson is recalling Inflectra (infliximab-dyyb) injectable drug due to manufacturing quality deviations. A batch intended for quarantine was inadvertently distributed to patients nationwide.
Product
INFLECTRA — INFLECTRA (INFLIXIMAB-DYYB)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2025·2025-02-05
HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2025·2025-02-05
Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2025·2025-02-05
Knee Implant Component Recalled for Incorrect Metal Post Assembly
Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2025·2025-02-05
Medtronic Percutaneous Reference Pins May Not Fit Properly
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Product
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2025·2025-02-05
Medical stent delivery system outer sheath component detachment prevents proper expansion
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1058-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2025·2025-02-05
Alphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
Product
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 d
Category
Medical Device
Distribution
Distributed nationwide