State

Tennessee product recalls

20,305 recalls have nationwide distribution and so reach Tennessee. 0 additional recalls listed Tennessee specifically in their distribution scope.

About recalls in Tennessee

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Tennessee consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12176–12200 of 20305

HighFDA (Drugs)·D-1011-2023·2023-08-09
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2023·2023-08-09
Medline procedural kits may contain non-sterile ultrasound gel
Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Failure
Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2023·2023-08-09
X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts
Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.
Product
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2023·2023-08-09
Philips CT scanner heat exchanger box may detach and cause injury
The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.
Product
Incisive CT-Computed Tomography X-Ray System Model: 728143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1058-2023·2023-08-09
HYDROmorphone Injection Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 2,077 syringes of HYDROmorphone injection (15 mg/30 mL) distributed nationwide due to lack of validation data for sanitization cycles. No adverse events have been reported.
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1022-2023·2023-08-09
Cardioplegia Solution IV bags recalled for missing sterility validation
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-252142) nationwide because decontamination validation data is lacking, preventing assurance of sterility.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2023·2023-08-09
Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns
Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2023·2023-08-09
Image intensifier detachment hazard in OEC fluoroscopy imaging systems
GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.
Product
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1017-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1073-2023·2023-08-09
ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps
Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.
Product
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1002-2023·2023-08-09
Neonatal TPN IV Bags Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services recalled 96 neonatal TPN IV bags (Lot 36-256336) due to lack of sterility assurance and missing validation data for decontamination cycles. The product was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2023·2023-08-09
ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems
A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.
Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2310-2023·2023-08-09
Custom Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2023·2023-08-09
OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.
Product
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2023·2023-08-09
SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays
Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Mode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1016-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
Product
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1010-2023·2023-08-09
FDA Recalls Neonatal TPN Bags for Inadequate Sterility Validation
Central Admixture Pharmacy Services is recalling 192 bags of Neonatal TPN Starter Bag distributed nationwide due to lack of sterilization validation. The company cannot assure the product's sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2023·2023-08-09
X-ray therapy system carriage bolts may loosen and suspension rail crack
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
Product
Azurion 7 M20. X-ray Image guided Therapy System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1079-2023·2023-08-09
Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2023·2023-08-09
OEC 9900 Systems Image Intensifier Detachment and Fall Risk
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Product
OEC 9900 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1029-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 144 bags of Cardioplegia Solution nationwide because validation data for sterilization cycles is lacking.
Product
CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1026-2023·2023-08-09
IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Product
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1065-2023·2023-08-09
Morphine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 720 syringes of morphine due to lack of validation data for sanitization cycles, which creates uncertainty about product sterility. The product was distributed nationwide.
Product
morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3
Category
Drug
Distribution
Distributed nationwide