October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical: 4
Severe: 93
High: 442
Moderate: 62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

Which agencies issued them

501–600 of 601

HighFDA (Devices)·Z-3248-2024·2024-10-02
Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Product
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3234-2024·2024-10-02
Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
Product
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0663-2024·2024-10-02
Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
Product
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3243-2024·2024-10-02
Medical device kit recalled due to inability to confirm sterilization assurance
American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.
Product
Cysto, FTCY03L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3191-2024·2024-10-02
Custom Procedure Kit Sheath Introducers Mislabeled by Size
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Product
Custom Procedure Kit, REF: K12T-11077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3251-2024·2024-10-02
Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Product
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3259-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3195-2024·2024-10-02
Philips Ingenia 3.0T MRI Scanner Tabletop Blockage Risk
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
Product
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3273-2024·2024-10-02
Wallflex and Agile Esophageal Stent Systems Recalled Due to Catheter Tip Detachment Risk
Boston Scientific is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over the Wire Stent System due to potential delivery catheter tip detachment during placement. Wallflex devices totaling 115 units are affected.
Product
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3080-2024·2024-10-02
GE Giraffe Warmer Recalled for Incomplete Electrical Safety Testing
Wipro GE Healthcare is recalling specific GE Giraffe Warmers because incomplete electrical safety testing during manufacturing may allow leakage current to exceed safety limits.
Product
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3280-2024·2024-10-02
FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3283-2024·2024-10-02
Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1835-2024·2024-10-02
Codfish Frying Mix Recalled for Undeclared Fish Allergen
Avole, Inc. is recalling Bacalaitos Criollos Codfish Frying Mix (7 oz.) distributed in Puerto Rico because fish allergen is not declared on the product label.
Product
Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-3279-2024·2024-10-02
Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3281-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2024·2024-10-02
WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
Product
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3296-2024·2024-10-02
Origio Sperm Wash Medium Recalled Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.
Product
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3287-2024·2024-10-02
Esophageal Stent Systems Recalled for Potential Delivery Catheter Detachment
Boston Scientific is recalling esophageal stent systems due to potential delivery catheter tip detachment during placement. Patients and providers with affected devices should contact the manufacturer for guidance.
Product
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V737000·2024-10-02
2025 Chevrolet Equinox EV door strikers recalled for possible breakage
General Motors is recalling 2025 Chevrolet Equinox EV vehicles (along with Blazer and Blazer EV models) because door strikers may not be properly heat-treated and could break, causing doors to open unexpectedly. All affected vehicles remain in dealerships.
Product
CHEVROLET — CHEVROLET BLAZER EV, EQUINOX EV, BLAZER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1820-2024·2024-10-02
Montreal Fudge Chocolate Fudge with Nuts Recalled for Mold Contamination
Authentik Fudge is recalling Montreal Fudge brand Chocolate Fudge with Nuts due to potential mold contamination. The affected products were distributed through TJ Maxx and Marshalls locations.
Product
Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz
Category
Food
Distribution
40 states
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3222-2024·2024-10-02
FDA Recalls Karl Storz Endoscopes Due to Unapproved Reprocessing Instructions
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
Product
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3250-2024·2024-10-02
Cook Biotech Biodesign Fistula Plug implants recalled for premature expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPB-0.4 implants because products expire before their printed expiration dates.
Product
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3295-2024·2024-10-02
Boston Scientific Agile Esophageal Stent Recall: Catheter Tip Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.
Product
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3237-2024·2024-10-02
Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Product
Hand Pack, AKHD97C; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3190-2024·2024-10-02
Prelude Sheath Introducer 7.5F devices recalled due to labeling error
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
Product
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3249-2024·2024-10-02
IntelliVue Patient Monitors recalled for electrical grounding defect
Philips is recalling approximately 545 IntelliVue Patient Monitor units with a broken ground bolt that may cause loss of electrical grounding, potentially affecting the device's electromagnetic immunity and emission.
Product
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3216-2024·2024-10-02
ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
Product
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3288-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.
Product
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3228-2024·2024-10-02
Endovascular AAA Pack recalled for sterilization assurance failure
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Product
Endovascular AAA Pack, ESED52B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3256-2024·2024-10-02
Biodesign Fistula Plug Implant Recalled for Premature Expiration
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
Product
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3218-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1823-2024·2024-10-02
M&P Food Products Cheese Blintzes Recalled for Undeclared Wheat
M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.
Product
M&P Food Products Cheese Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk, eggs, margarine, sugar, salt; FILLING INGREDIENTS: Farmer Cheese; Cheese Blintzes; UPC: 707163303251
Category
Food
Distribution
7 states
HighFDA (Food)·F-1829-2024·2024-10-02
M&P Food Vareniki Products Recalled for Undeclared Wheat
M&P Food Productions is recalling Potato & Mushroom Vareniki because the products contain undeclared wheat, which poses a risk to consumers with wheat allergies.
Product
Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPC: 707163026174
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3274-2024·2024-10-02
WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1831-2024·2024-10-02
Marionberry Scones Recalled for Undeclared Soy Allergen
Skagit River Bakery & Cafe is recalling marionberry scones distributed in Washington due to undeclared soy lecithin and soybean oil on labels. Consumers with soy allergies should not consume this product.
Product
Marionberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the ingredients used in the scones.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-3245-2024·2024-10-02
FDA Recalls Surgical Instrument Handle That May Break During Use
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3263-2024·2024-10-02
Ostomy barrier seals recalled for blistering and incorrect model labeling
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
Product
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-3205-2024·2024-10-02
MRI diagnostic device screws may loosen and block tabletop
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Product
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3258-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3192-2024·2024-10-02
Biopsy instrument packaging holes compromise sterile barrier integrity
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Product
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1827-2024·2024-10-02
Sour Cherry Vareniki Recalled for Undeclared Wheat Allergen
M & P Food Productions is recalling Sour Cherry Vareniki frozen dumplings due to undeclared wheat, a major allergen not listed on the label.
Product
Sour Cherry Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Sour Cherry, Sugar; UPC: 707163026150
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3197-2024·2024-10-02
MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Product
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3213-2024·2024-10-02
Cervical disc implant recalled due to foreign contamination during assembly
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3290-2024·2024-10-02
Esophageal stent systems recalled due to delivery catheter defect
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Product
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3081-2024·2024-10-02
GE Panda iRES infant warmer electrical safety testing incomplete
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
Product
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10)…
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1830-2024·2024-10-02
Farmer Cheese Vareniki recalled for undeclared wheat and milk allergens
M&P Food Productions is recalling Farmer Cheese Vareniki due to undeclared wheat and milk allergens. The frozen product was distributed across seven states from August 2023 to August 2024.
Product
Farmer Cheese Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Farmer Cheese; UPC: 707163026181
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3275-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1826-2024·2024-10-02
M&P Delicacies Pirozhki Pies Recalled for Undeclared Wheat and Milk
M&P Food Productions recalls frozen Pirozhki pies distributed across multiple states due to undeclared wheat and milk in the product. Consumers with wheat or milk allergies should not consume these products.
Product
M&P Delicacies PIROZHKI (PIES) with CABBAGE; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: cabbage, carrot, sauerkraut, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3299-2024·2024-10-02
Arrow Arterial Kits Recalled Due to Open Packaging Seals
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Product
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1825-2024·2024-10-02
M&P Delicacies Pirozhki Frozen Pies Recalled for Undeclared Wheat and Milk
M&P Delicacies frozen pirozhki pies contain undeclared wheat and milk allergens. Consumers with allergies to these ingredients should not consume the product.
Product
M&P Delicacies PIROZHKI (PIES) with POTATOES; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Potatoe, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN
Category
Food
Distribution
7 states
HighFDA (Drugs)·D-0660-2024·2024-10-02
Mupirocin Antibiotic Ointment Recalled Nationwide Due to Subpotency
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
Product
MUPIROCIN — MUPIROCIN (MUPIROCIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3241-2024·2024-10-02
American Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Product
ENT, COEN27N; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3302-2024·2024-10-02
Cardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Product
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3291-2024·2024-10-02
Boston Scientific Esophageal Stent Systems Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.
Product
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3158-2024·2024-10-02
Mobile X-Ray System Exposure Settings May Not Apply Correctly
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Product
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1828-2024·2024-10-02
Potato and Onion Vareniki Recalled Due to Undeclared Wheat
M&P Food Productions is recalling Potato & Onion Vareniki due to undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.
Product
Potato & Onion Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Fried Onion; UPC: 707163026167
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3297-2024·2024-10-02
CooperSurgical Recalls Origio Sperm Wash Medium Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3215-2024·2024-10-02
Siemens ACUSON Juniper ultrasound systems software unit conversion error
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Product
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3255-2024·2024-10-02
Biodesign Fistula Plug Implants Recalled Due to Premature Expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Product
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1824-2024·2024-10-02
M&P Delicacies Pirozhki Pies Recalled for Undeclared Wheat and Milk
M&P Delicacies Pirozhki (pies) are recalled due to undeclared wheat and milk in the product. Consumers with allergies to these ingredients should not consume the product.
Product
M&P Delicacies PIROZHKI (PIES) with Black Currant; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Black currant, sugar, farina; 1 SERVING READY TO EAT; KEEP FROZEN
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3236-2024·2024-10-02
Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure
American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.
Product
Neuro Vascular, ANKV91A; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3242-2024·2024-10-02
Nasal Sinus Pack Recalled Due to Sterilization Verification Failure
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
Product
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3268-2024·2024-10-02
FDA Recalls Esophageal Stent Systems for Potential Catheter Tip Detachment
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3269-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1822-2024·2024-10-02
M&P Food Products Frozen Blintzes Recalled for Undeclared Wheat
M&P Food Products Cheese & Cherry Blintzes are recalled because they contain undeclared wheat. Consumers with wheat allergies should not consume this product.
Product
M&P Food Products Cheese & Cherry Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk; eggs, margarine; sugar, salt; FILLING INGREDIENTS: Farmer Cheese, cherries; Cheese & Cherry Blintzes Net Wt. 14 OZ. (396g) UPC…
Category
Food
Distribution
7 states
HighFDA (Food)·F-1833-2024·2024-10-02
Pickled Garlic Product Recalled for Undeclared Fish Allergen
Shiso Katsuo Ninniku pickled garlic products are being recalled due to an undeclared fish allergen. The recall affects 9,482 units distributed across seven states.
Product
Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3700
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3239-2024·2024-10-02
Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
Product
Cath Lab Pack, CECL02P; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3233-2024·2024-10-02
Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Product
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3270-2024·2024-10-02
Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1834-2024·2024-10-02
Imported Pickled Garlic Recalled for Undeclared Fish Allergen
Niitakaya USA Inc is recalling Miso Katsuo Ninniku pickled garlic because it contains undeclared fish allergen. Consumers with fish allergies should not consume this product.
Product
Miso Katsuo Ninniku (Pickled Garlic), Net WT 5.2 OZ (147g) Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3701
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3298-2024·2024-10-02
Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3230-2024·2024-10-02
American Contract Systems Recalls Open Shoulder Medical Convenience Kits
American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.
Product
Open Shoulder, LWOS39L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3219-2024·2024-10-02
Karl Storz Hopkins Telescope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Product
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1821-2024·2024-10-02
54th St Blackened Sauce Recalled for Undeclared Soy Allergen
54th St Blackened Sauce is being recalled because soy allergen is present in the product but missing from the label's Contains statement. Consumers with soy allergies should not consume it.
Product
54th St Blackened Sauce, 9lb bags - 4 bags per case.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-3278-2024·2024-10-02
FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3231-2024·2024-10-02
Day Surgery General Pack medical kit recalled for sterilization concern
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Product
Day Surgery General Pack, FHGE18T; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3293-2024·2024-10-02
Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
Product
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3210-2024·2024-10-02
AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction
Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.
Product
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3225-2024·2024-10-02
Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3196-2024·2024-10-02
Philips Ingenia 3.0T CX MRI Machine Carrier Assembly Screws May Loosen
Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.
Product
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3254-2024·2024-10-02
Cook Biotech Recalls Biodesign Fistula Plug Due to Early Expiration
Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.
Product
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3189-2024·2024-10-02
Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
Product
Stainless Steel Sims Uterine Sound, Part Number 64-601
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3214-2024·2024-10-02
GE Centricity PACS Image Storage Failure When Maximum Identifiers Reached
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
Product
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3188-2024·2024-10-02
CooperSurgical Recalls Silver-Plated Copper Sims Uterine Sound for Incorrect Marking
CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.
Product
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3253-2024·2024-10-02
Cook Biotech Recalls Biodesign Fistula Plugs Due to Expiration Date Errors
Cook Biotech is recalling 93 Biodesign Fistula Plugs because the products expire prior to the expiration date printed on the labeling.
Product
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3220-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
Product
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0662-2024·2024-10-02
Sunscreen product recalled for microbial contamination nationwide
SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.
Product
SHEET SPF 30 MINERAL — SHEET SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0667-2024·2024-10-02
Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations
EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.
Product
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-3261-2024·2024-10-02
Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
Product
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·24V732000·2024-10-01
2021-2024 Porsche Taycan battery short circuit fire risk
Porsche is recalling 2021-2024 Taycan vehicles due to high-voltage battery short circuits that increase fire risk. Dealers will install diagnostic software and replace batteries as needed, advising owners to charge only to 80% capacity until repairs are completed.
Product
PORSCHE — PORSCHE TAYCAN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24E082000·2024-10-01
Chrysler Recalls Steering Column Modules for Turn Signal Defect
Chrysler is recalling specific MOPAR steering column control modules because the turn signal self-canceling feature may not function properly, increasing crash risk.
Product
EXTERIOR LIGHTING:TURN SIGNAL recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V731000·2024-10-01
2020-2023 Porsche Taycan Recalled for High-Voltage Battery Short Circuit Risk
Porsche is recalling 2020-2023 Taycan vehicles due to a potential short circuit in the high-voltage battery that increases fire risk. Owners should limit charging to 80% until dealers replace the affected battery modules.
Product
PORSCHE — PORSCHE TAYCAN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V736000·2024-10-01
2025 Daimler Trucks Fuel Pump Barrel Fracture Recall
Daimler Trucks North America is recalling certain 2025 commercial trucks with Cummins fuel pumps that may fracture and leak fuel, potentially causing engine stall. No injuries have been reported.
Product
WESTERN STAR — WESTERN STAR, FREIGHTLINER, FCCC 49X, CASCADIA, XCM, XCP
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V734000·2024-10-01
2025 International HX and LT vehicles recalled for fuel pump fracture risk
Navistar is recalling 2025 International HX and LT vehicles with Cummins X15 diesel engines due to fuel pump barrel fracture risk. The fracture can cause fuel leaks and engine stalls, increasing crash risk.
Product
INTERNATIONAL — INTERNATIONAL HX, LT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V730000·2024-10-01
Porsche Recalls 2025 Taycan for Delayed Rearview Camera Display
Porsche is recalling 2025 Taycan vehicles because the rearview camera image may not display immediately when shifting into reverse, increasing crash risk.
Product
PORSCHE — PORSCHE TAYCAN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V729000·2024-10-01
Ram 1500 Recalled for Turn Signal Self-Canceling Defect
Chrysler is recalling 2023-2024 Ram 1500 vehicles because the turn signal self-canceling feature may not function properly, increasing crash risk.
Product
RAM — RAM 1500
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V735000·2024-10-01
Navistar Recalls 2025 International CV Vehicles Due to Inactive Air Bags
Navistar is recalling 2025 International CV vehicles because air bag modules may not have been activated during installation, increasing injury risk in crashes.
Product
INTERNATIONAL — INTERNATIONAL CV
Category
Vehicle
Distribution
Distributed nationwide

Looking for a different month? Back to 2024.