State

South Carolina product recalls

73,827 recalls have nationwide distribution and so reach South Carolina. 7,153 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total: 7,153
Critical: 1,275
Severe: 2,170
Most recent: 2026-11-04

Of the 7,153 recalls naming South Carolina we have scored against our rubric, 1,275 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,170 (30%) are Severe.

Which agencies issued them

These figures cover only the 7,153 recalls whose distribution notice names South Carolina specifically. The 73,827 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

52351–52375 of 80980

HighFDA (Devices)·Z-2388-2016·2016-08-17
Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings
Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.
Product
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2379-2016·2016-08-17
Merge PACS software recalled due to patient name mismatch
Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.
Product
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2016·2016-08-17
Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect
Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.
Product
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2374-2016·2016-08-17
Teleflex Servo Humidifier 163 Recalled Due to Connector Cracks
Teleflex Medical is recalling Servo Humidifier 163 units because cracks may occur at the ISO female connectors.
Product
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2385-2016·2016-08-17
Philips Ingenuity CT Software Recall for Performance Issues
Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Product
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2376-2016·2016-08-17
Hill-Rom Recalls Volker Series Hospital Beds Due to Side Rail Defect
Hill-Rom is recalling Volker 2080, 2082, S 280, and S 282 series hospital beds because the side rail latch may fail, causing the rail to lower and the patient to fall.
Product
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·16245·2016-08-17
Xenith Recalls Football Helmets Due to Shell Cracking Hazard
Xenith is recalling specific football helmets because the shells can crack, posing a risk of head injuries. No injuries have been reported.
Product
Football helmets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2396-2016·2016-08-17
Stryker Recalls Exeter Rasp Handle Due to Malfunctioning
Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.
Product
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2398-2016·2016-08-17
Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect
Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.
Product
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2016·2016-08-17
Philips MX 16-slice CT Systems Recalled for Software Defects
Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.
Product
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2353-2016·2016-08-17
Stryker S3 MedSurg Bed Fowler Control Failure Recall
Stryker is recalling S3 MedSurg Beds because CPU board failures can cause the backrest electronic controls to stop working.
Product
S3 MedSurg Bed, Model 3005. Stryker Medical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2016·2016-08-17
Ortho VITROS Estradiol Reagent Recall Due to Fulvestrant Cross-Reactivity
Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.
Product
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2016·2016-08-17
Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect
Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.
Product
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2377-2016·2016-08-17
Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues
Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.
Product
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2367-2016·2016-08-17
Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-2382-2016·2016-08-17
Philips Brilliance iCT SP CT Scanner Software Recall
Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.
Product
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2383-2016·2016-08-17
Philips CT Scanner Software Recall for Performance Issues
Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.
Product
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2380-2016·2016-08-17
Philips Brilliance 64 CT Scanner Software Recall
Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.
Product
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2368-2016·2016-08-17
Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-2344-2016·2016-08-17
Siemens Artis Angiography Systems Recalled for Image Reproduction Failure
Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.
Product
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2384-2016·2016-08-17
Philips Ingenuity CT Software Recall for Performance Issues
Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Product
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2372-2016·2016-08-17
Philips Ingenuity Core 128 CT Systems Recalled for Software Defect
Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.
Product
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-2346-2016·2016-08-17
Philips MX 16-slice CT System Software Recall for Data Integrity Issues
Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.
Product
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2394-2016·2016-08-17
Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination
Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.
Product
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2364-2016·2016-08-17
Invacare Pediatric Flowmeter Recalled for Upside-Down Rear Scale Printing
Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may cause confusion during oxygen flow monitoring.
Product
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the…
Category
Medical Device
Distribution
30 states