State

South Carolina product recalls

72,986 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 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7551–7575 of 80103

HighFDA (Devices)·Z-1385-2025·2025-03-26
Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2025·2025-03-26
Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
Product
CV BASIC PUMP PACK , Model No WECV23D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2025·2025-03-26
Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.
Product
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2025·2025-03-26
Labor and Delivery Pack Recalled Over Unconfirmed Sterilization
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
Product
LABOR & DELIVERY PACK, Model Nos LLLD19H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2025·2025-03-26
Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
Product
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2025·2025-03-26
Laceration Trays Recalled Due to Sterility Assurance Concerns
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0290-2025·2025-03-26
Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1351-2025·2025-03-26
EAR PACK Medical Device Recalled Over Unconfirmed Sterilization
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
Product
EAR PACK , Model No SFEA12A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0279-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
Product
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2025·2025-03-26
DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Product
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2025·2025-03-26
CYSTO Model SACY80R Recall for Sterilization Assurance Failure
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
Product
CYSTO , Model No SACY80R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2025·2025-03-26
Candida ID Antigen recalled for reduced sensitivity, potential false negatives
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Product
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0286-2025·2025-03-26
Injectable Drug Recalled for Stability Issues at Expiration
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
Product
NEUPOGEN — NEUPOGEN (FILGRASTIM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Product
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2025·2025-03-26
PICC Line Catheters Recalled for Sterilization Assurance Issues
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
Product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0278-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.
Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2025·2025-03-26
Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
Product
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0277-2025·2025-03-26
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2025·2025-03-26
Sterile surgical drapes recalled due to potential packaging breach
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
Product
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2025·2025-03-26
Delivery Pack Medical Device Sterilization Assurance Not Confirmed
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
Product
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2025·2025-03-26
Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2025·2025-03-26
Proxima Drape surgical drapes recalled due to potential sterility loss
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2025·2025-03-26
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Category
Medical Device
Distribution
Distributed nationwide