State

South Carolina product recalls

73,376 recalls have nationwide distribution and so reach South Carolina. 7,145 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total: 7,145
Critical: 1,278
Severe: 2,166
Most recent: 2026-09-23

Of the 7,145 recalls naming South Carolina we have scored against our rubric, 1,278 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,166 (30%) are Severe.

Which agencies issued them

These figures cover only the 7,145 recalls whose distribution notice names South Carolina specifically. The 73,376 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

18876–18900 of 80521

HighFDA (Devices)·Z-1046-2023·2023-02-08
Medline UNITE Foot & Ankle Screw Recalled for Intra-Operative Failure
Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.
Product
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2023·2023-02-08
Non-sterile procedural knee trays recalled for potential packaging breach
Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.
Product
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2023·2023-02-08
Cardiopulmonary Bypass Oxygenator Recalled for Loose Temperature Monitoring Adapter
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2023·2023-02-08
Procedural Trays with Sterile Blades May Have Damaged Packaging
Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.
Product
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2023·2023-02-08
Non-sterile orthopedic procedural trays recalled for potential sterile packaging breach
Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.
Product
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1026-2023·2023-02-08
Affinity Fusion Oxygenator adapter may loosen during cardiac surgery
Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2023·2023-02-08
OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
Product
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1024-2023·2023-02-08
Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery
The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2023·2023-02-08
Bard Catheter Repair Kits Recalled for Hardened, Unusable Adhesive
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
Product
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2023·2023-02-08
MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure
MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.
Product
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2023·2023-02-08
Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2023·2023-02-08
Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
Product
AxiEM" Non-Invasive Patient Tracker
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1037-2023·2023-02-08
Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2023·2023-02-08
Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall
Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2023·2023-02-08
Non-sterile procedural trays with potential sterile packaging breach
Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.
Product
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2023·2023-02-08
GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0262-2023·2023-02-08
Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications
Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2023·2023-02-08
SynCardia Total Artificial Heart System Recalled for Cannula Tears
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
Product
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2023·2023-02-08
Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
Product
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2023·2023-02-08
Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk
Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.
Product
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2023·2023-02-08
Non-sterile procedural trays risk sterile packaging breach
Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.
Product
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2023·2023-02-08
MEDLINE procedural trays recalled for potential sterile packaging breach
MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.
Product
Non-sterile procedural trays labeled as CRANI, 2 per case
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·23115·2023-02-08
Fabuloso Multi-Purpose Cleaners Recalled for Bacterial Contamination Risk
Colgate-Palmolive is recalling about 4.9 million Fabuloso Multi-Purpose Cleaners due to contamination with Pseudomonas bacteria. People with weakened immune systems, external medical devices, or underlying lung conditions face a risk of serious infection from exposure.
Product
Fabuloso Multi-Purpose Cleaners
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2023·2023-02-08
Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators
Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0323-2023·2023-02-08
Vitamin B Complex dietary supplement recalled due to undeclared niacin
Professional Complementary Health Formulas, LLC recalls Vitamin B Complex dietary supplement (lot 1092715) due to undeclared niacin affecting 299 bottles distributed nationwide.
Product
Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin)…
Category
Food
Distribution
Distributed nationwide