February 2024 recalls

677 recalls were announced in February 2024.

What the numbers show

Critical: 21
Severe: 161
High: 456
Moderate: 38
Low: 1

Of the 677 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

Which agencies issued them

501–600 of 677

HighFDA (Devices)·Z-0937-2024·2024-02-07
EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
Product
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0283-2024·2024-02-07
Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures
Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-0915-2024·2024-02-07
Knee Replacement Implant Recall Due to Potential Material Oxidation
Howmedica Osteonics Corp. is recalling LARGE PRIMARY REV.TIB.INSERT-DURACON knee implants manufactured with aged UHMWPE material that may have elevated oxidation levels. Affected patients should consult their healthcare provider.
Product
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0875-2024·2024-02-07
Knee replacement implant recalled for potential material oxidation
Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0801-2024·2024-02-07
Benny T's Vesta hot sauce recalled for undeclared wheat allergen
Benny T's Vesta Dry Hot Sauce is recalled because wheat is not listed on the label, despite being present in the breadcrumbs ingredient. Consumers with wheat allergies should not consume this product.
Product
the original BENNY T'S VESTA DRY HOT SAUCE VERY HOT NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99499 7 (Habanero & Scotch…
Category
Food
Distribution
24 states
HighFDA (Devices)·Z-0907-2024·2024-02-07
Knee replacement inserts recalled for potential material oxidation
Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.
Product
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0900-2024·2024-02-07
Scorpio NRG Tibial Bearing Insert Assembly Recall Due to Material Oxidation Risk
Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Bearing Insert Assemblies manufactured with raw material over 5 years old, which may develop elevated oxidation affecting implant durability.
Product
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0887-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0871-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.
Product
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2024·2024-02-07
SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk
Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.
Product
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2024·2024-02-07
Tank hose assembly recalled for incorrect material and missing perforations
AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.
Product
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0826-2024·2024-02-07
Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure
American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2024·2024-02-07
NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail
A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.
Product
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
Category
Medical Device
Distribution
17 states
HighUSDA FSIS·PHA-02072024-01·2024-02-07
Frozen Chicken Pilaf Recalled Due to Rock Contamination
USDA issued a public health alert for frozen Trader Joe's chicken pilaf due to rock contamination. One consumer reported a dental injury.
Product
Mama Vicky's Inc. — FSIS Issues Public Health Alert For Frozen Ready-To-Eat Chicken Pilaf Products Due to Possible Foreign Matter Contamination
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0836-2024·2024-02-07
Medical sterilization chemical integrators recalled due to labeling discrepancy
TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.
Product
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0874-2024·2024-02-07
Knee replacement tibial insert recalled for potential material oxidation
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0876-2024·2024-02-07
Knee Implant Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2024·2024-02-07
Knee implant component recalled due to potential material oxidation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
Product
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2024·2024-02-07
Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement
Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2024·2024-02-07
EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
Product
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2024·2024-02-07
Budesonide Extended-Release Tablets recalled for failed dissolution specifications
Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.
Product
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0922-2024·2024-02-07
Knee replacement implant recalled for potential material oxidation risk
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
Product
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0872-2024·2024-02-07
Knee replacement implant recalled for material oxidation risk
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
Product
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0821-2024·2024-02-07
Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0825-2024·2024-02-07
Surgical Procedure Kits Recalled Due to Improper Sterilization
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
Product
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2024·2024-02-07
Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
Product
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2024·2024-02-07
MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk
Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.
Product
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2024·2024-02-07
Surgical kits for childbirth recalled for sterilization and functionality risks
American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2024·2024-02-07
MRI Machine Coil Seal Adhesive May Create Sharp Edges
The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.
Product
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2024·2024-02-07
Knee replacement implant recalled due to potential material degradation
Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.
Product
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2024·2024-02-07
FX SHOULDER Centered Glenosphere with Screw may contain eccentric component
FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2024·2024-02-07
Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0908-2024·2024-02-07
Knee Replacement Inserts Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
Product
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0800-2024·2024-02-07
Hot Sauce Recalled for Missing Wheat Allergen Labeling
Benny T's Vesta Dry Hot Sauce is recalled for labeling that fails to disclose wheat and other ingredient common names. The missing allergen information poses a risk to consumers with wheat allergies.
Product
the original BENNY T'S VESTA DRY HOT SAUCE SCORPION NWT WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99491 1 (Trinidad Moruga…
Category
Food
Distribution
24 states
HighFDA (Devices)·Z-0883-2024·2024-02-07
Knee replacement implant insert recalled due to material oxidation risk
Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2024·2024-02-07
Knee Replacement Implants Recalled for Potential Material Oxidation
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0285-2024·2024-02-07
Rifampin Capsules Recalled Due to Failed Impurity and Degradation Specification
Amerisource Health Services is recalling Rifampin 150 mg capsules because they failed to meet impurity and degradation specifications. The recall affects 1,568 cartons distributed nationwide.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2024·2024-02-07
Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.
Product
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures
American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2024·2024-02-07
Knee Replacement Component Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.
Product
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2024·2024-02-07
FDA Recalls SCORPIO U-DOME Knee Implants for Potential Material Oxidation
Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0797-2024·2024-02-07
Hot Sauce Recalled for Missing Wheat Allergen Labeling
Benny T's Vesta Dry Hot Sauce is recalled because its label does not list wheat and other required ingredient common names, posing a risk to consumers with wheat allergies.
Product
the original BENNY T'S VESTA DRY HOT SAUCE GHOST NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99498 0 (Habanero & Bhut…
Category
Food
Distribution
24 states
HighNHTSA·24V074000·2024-02-07
Eldorado XHF and Arrivo Recalled for Wheelchair Lift Beacon Defect
Eldorado is recalling 2012-2023 XHF and Arrivo vehicles because wheelchair lift warning beacons may be too dim, increasing injury risk.
Product
ELDORADO — ELDORADO XHF, ARRIVO
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0812-2024·2024-02-07
ToYou Snacks Mango Yogurt Bars Recalled for Undeclared Soy Allergen
Font Group of America Corp. is recalling ToYou Snacks brand Mango Yogurt bars due to undeclared soy allergen. Affected units were distributed in the United States.
Product
Mango Yogurt bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
Category
Food
Distribution
0 states
HighNHTSA·24V079000·2024-02-07
Blue Bird Recalls Transit Buses Due to Incorrectly Installed Seats
Blue Bird is recalling 2021-2023 Vision and All American transit buses because convertible seats may be incorrectly installed, posing a crash injury risk.
Product
BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2024·2024-02-07
Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging
Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.
Product
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0873-2024·2024-02-07
Series II Tibial Bear Insert Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2024·2024-02-07
Knee replacement tibial insert recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.
Product
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0811-2024·2024-02-07
Mint Dark Chocolate bars recalled for undeclared soy allergen
Font Group of America is recalling Mint Dark Chocolate bars (ToYou Snacks Brand) due to undeclared soy allergen. Consumers with soy allergies should not consume the product.
Product
Mint Dark Chocolate bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0889-2024·2024-02-07
Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2024·2024-02-07
Knee replacement implant insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.
Product
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0816-2024·2024-02-07
Coconut Mocha snack bars recalled for undeclared soy allergen
Font Group of America Corp. is recalling ToYou Snacks Brand Coconut Mocha bars (5,670 units) distributed in the United States due to undeclared soy allergen. Consumers with soy allergies should not consume this product.
Product
Coconut Mocha, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0823-2024·2024-02-07
Urological procedural kits recalled due to sterilization defects
American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2024·2024-02-07
Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces
Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.
Product
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2024·2024-02-07
Knee Replacement Implant Recalled Due to Material Oxidation Risk
Howmedica Osteonics recalled Scorpio Total Knee prosthetics with UHMWPE components produced from raw material over 5 years old, which may develop elevated oxidation and affect implant properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2024·2024-02-07
Knee replacement component recalled due to potential material oxidation
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0799-2024·2024-02-07
Benny T's Vesta Hot Sauce Recalled for Undeclared Wheat Allergen
Benny T's Vesta Dry Hot Sauce is recalled because wheat is not declared in the ingredient statement. The missing wheat label poses a risk to consumers with wheat allergies.
Product
the original BENNY T'S VESTA DRY HOT SAUCE REAPER NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99490 4 (Carolina Reaper)
Category
Food
Distribution
24 states
HighFDA (Devices)·Z-0951-2024·2024-02-07
Philips Ingenia 3.0T CX MRI: Loose Coil Seal May Cause Sharp Edges
Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during scanning.
Product
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2024·2024-02-07
PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2024·2024-02-07
Knee Replacement Implant Insert Recalled Due to Material Degradation Risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.
Product
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V078000·2024-02-07
Blue Bird Recalls School Buses Due to Improperly Installed Convertible Seats
Blue Bird is recalling 2020-2024 Vision and All American school buses because convertible seats may be incorrectly installed, creating a risk of injury during a crash.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2024·2024-02-07
Knee Replacement Component Recalled Due to Raw Material Oxidation Risk
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2024·2024-02-07
Knee replacement implants recalled for potential material degradation
Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.
Product
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0806-2024·2024-02-07
Aldi Choceur Burnt Caramel Chocolate Bars Recalled for Undeclared Coconut
Astor Chocolate Corp. has recalled Aldi Choceur Burnt Caramel Chocolate Bars due to undeclared coconut, a common allergen. The voluntary recall involves 1,092 units distributed to a distribution center in Florida.
Product
Aldi Choceur Burnt Caramel Chocolate Bars, Net Wt. 1.75oz. UPC 4099100202809
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0938-2024·2024-02-07
EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
Product
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2024·2024-02-07
Knee Replacement Implant Component Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0845-2024·2024-02-07
Surgical sutures recalled due to substandard gamma sterilization doses
Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.
Product
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0824-2024·2024-02-07
Custom Surgical Convenience Kits May Lack Proper Sterilization Validation
American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.
Product
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2024·2024-02-07
Knee replacement devices recalled due to potential material degradation
Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0832-2024·2024-02-07
Ophthalmic procedural kits recalled due to inadequate sterilization validation
American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2024·2024-02-07
Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement
TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.
Product
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0965-2024·2024-02-07
Medline Blood Culture Collection Kit Recalled for Expired Bactec Component
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0956-2024·2024-02-07
Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk
A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.
Product
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0796-2024·2024-02-07
Dried plums recalled due to undeclared sulfites
Win Luck Trading Inc recalled Tasty Snacks Plum Queen Dried Plums (7 ounce cans, code 12122023) because the product contains undeclared sulfites, a food allergen.
Product
Tasty Snacks Plum Queen Dried Plums Net Weight 200G (7OZ) Packaged in cans. 30 cans per case.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0869-2024·2024-02-07
Knee replacement patella component recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.
Product
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2024·2024-02-07
Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
Product
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0275-2024·2024-02-07
FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution
FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.
Product
BUDESONIDE — BUDESONIDE (BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2024·2024-02-07
Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
Product
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2024·2024-02-07
Knee replacement inserts recalled due to material oxidation risk
P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.
Product
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0833-2024·2024-02-07
Orthopedic surgical kits recalled for unassessed external component sterilization
American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.
Product
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2024·2024-02-07
Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury
The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.
Product
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0828-2024·2024-02-07
Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects
American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2024·2024-02-07
Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2024·2024-02-07
Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation
Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.
Product
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0822-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0865-2024·2024-02-07
GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts
GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.
Product
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0950-2024·2024-02-07
Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail
Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.
Product
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2024·2024-02-07
Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges
Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.
Product
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2024·2024-02-07
SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2024·2024-02-07
Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure
Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.
Product
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0819-2024·2024-02-07
Cardiac central line insertion kits lack documented sterilization validation
American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0274-2024·2024-02-07
Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications
Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.
Product
CEFIXIME — CEFIXIME (CEFIXIME)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2024·2024-02-07
Tibial Knee Replacement Implants Recalled Due to Material Oxidation
Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.
Product
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2024·2024-02-07
Philips Achieva XR MRI Coil Seal Adhesive Failure Risk
Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.
Product
Achieva XR. Model (REF) Numbers 781153, 781253.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V077000·2024-02-07
2024 Kia Telluride recalled for engine valve spring failure
Kia is recalling certain 2024 Telluride vehicles because engine valve springs may break while driving. This could cause loss of drive power and increased risk of fire.
Product
KIA — KIA TELLURIDE
Category
Vehicle
Distribution
Distributed nationwide

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