State

South Carolina product recalls

72,940 recalls have nationwide distribution and so reach South Carolina. 7,116 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total: 7,116
Critical: 1,268
Severe: 1,870
Most recent: 2026-09-09

Of the 7,116 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 7,116 recalls whose distribution notice names South Carolina specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5176–5200 of 80056

HighFDA (Devices)·Z-0023-2026·2025-10-08
Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2026·2025-10-08
Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2026·2025-10-08
Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2026·2025-10-08
Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0677-2025·2025-10-08
Ketorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
Apotex is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution 0.5% because atypical weight loss from improper bottle sealing raises sterility concerns.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2673-2025·2025-10-08
Ophthalmic imaging software recalled over measured areas smaller than actual values
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.
Product
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2026·2025-10-08
Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2637-2025·2025-10-08
Junctional tourniquet devices recalled over manufacturing defect affecting structural integrity
North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.
Product
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2639-2025·2025-10-08
Radiosurgery systems recalled over software defect that could cause collimator collision
Zap Surgical Systems is recalling 17 ZAP-X Radiosurgery Systems because a software defect could let the collimator collide with a patient's shoulders or the patient table.
Product
ZAP-X Radiosurgery System, Model: 300150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0030-2026·2025-10-08
Radiology software recalled because reports may not display fully when viewed
Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.
Product
Change Healthcare Radiology Solutions software version 14.2.2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0017-2026·2025-10-08
Dental implants recalled after import under non compliant temperature and storage conditions
S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.
Product
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2026·2025-10-08
Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2026·2025-10-08
Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion
Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Product
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0006-2026·2025-10-08
Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion
Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2026·2025-10-08
Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Product
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0008-2026·2025-10-08
Allura Xper FD20 OR Table systems recalled over BIOS battery depletion
Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2026·2025-10-08
Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Product
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2025·2025-10-08
Vein ablation generators recalled over software falsely flagging working catheters
BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.
Product
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0034-2026·2025-10-08
Collagen vascular grafts recalled over unapproved bovine raw material supplier
LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.
Product
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2026·2025-10-08
Allura Xper FD20 Biplane OR Table systems recalled for BIOS battery failure
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0015-2026·2025-10-08
Allura Centron cardiovascular X-ray systems recalled over BIOS battery depletion
Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.
Product
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0013-2026·2025-10-08
Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion
Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0002-2026·2025-10-08
Entecavir 1 mg tablets recalled for out of specification organic impurity
Zydus is recalling 600 bottles of Entecavir Tablets USP 1 mg from one lot after an individual organic impurity returned an out-of-specification result.
Product
ENTECAVIR — ENTECAVIR (ENTECAVIR)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0675-2025·2025-10-08
Carbamazepine extended release tablets recalled after failing dissolution specifications
American Health Packaging is recalling 360 cartons of Carbamazepine Extended-Release Tablets USP 400 mg from one lot after the product failed dissolution specifications.
Product
CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0001-2026·2025-10-08
Entecavir 0.5 mg tablets recalled for out of specification organic impurity
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.
Product
ENTECAVIR — ENTECAVIR (ENTECAVIR)
Category
Drug
Distribution
Distributed nationwide