Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,562 results
Pharmaceutical
FDA Drugs
FDA DrugsPEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
Shilpa Medicare Limited
FDA DrugsClass II
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Aug 26, 2026Shilpa Medicare Limited
Medical DeviceFDA Devices
FDA DevicesBlanketrol II Model 222S; Thermal regulating system.
Gentherm Medical, LLC
FDA DevicesClass II
Blanketrol II Model 222S; Thermal regulating system.
Overheating of the 115V CPU board may cause the device to shut down.
Aug 26, 2026Gentherm Medical, LLC
PharmaceuticalFDA Drugs
FDA DrugsSelenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
American Regent, Inc.
FDA DrugsClass II
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsAtropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
American Regent, Inc.
FDA DrugsClass II
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder
restor3d Inc.
FDA DevicesClass II
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Aug 26, 2026restor3d Inc.
Medical DeviceFDA Devices
FDA DevicesAmerican Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.
American Contract Systems Inc
FDA DevicesClass II
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Aug 26, 2026American Contract Systems Inc
Medical DeviceFDA Devices
FDA DevicesSiemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Siemens Healthcare Diagnostics Products Ltd.
FDA DevicesClass II
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Aug 26, 2026Siemens Healthcare Diagnostics Products Ltd.
Medical DeviceFDA Devices
FDA DevicesOne-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Intersurgical Inc
FDA DevicesClass II
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
Aug 26, 2026Intersurgical Inc
Medical DeviceFDA Devices
FDA DevicesAmerican Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
American Contract Systems Inc
FDA DevicesClass II
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Aug 26, 2026American Contract Systems Inc
Medical DeviceFDA Devices
FDA DevicesHalyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
AVID Medical, Inc.
FDA DevicesClass II
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Aug 26, 2026AVID Medical, Inc.
Medical DeviceFDA Devices
FDA DevicesBeckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Siemens Healthcare Diagnostics, Inc.
FDA DevicesClass II
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Aug 26, 2026Siemens Healthcare Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesOne-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Intersurgical Inc
FDA DevicesClass II
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
Aug 26, 2026Intersurgical Inc
PharmaceuticalFDA Drugs
FDA DrugsMorphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Fresenius Kabi USA, LLC
FDA DrugsClass I
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Aug 26, 2026Fresenius Kabi USA, LLC
Medical DeviceFDA Devices
FDA DevicesOverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation
FDA DevicesClass II
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Aug 26, 2026Boston Scientific Corporation
Food & BeverageFDA Food
FDA FoodGet Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
GET FRESH PRODUCE
FDA FoodClass I
Get Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
Potential Salmonella contamination
Aug 26, 2026GET FRESH PRODUCE
Food & BeverageFDA Food
FDA FoodJalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged in assorted bulk package sizes (10lbs, 40lbs, 35lbs, 20lbs, 38lbs 1 1/9 Bushel) ; Product of MX; Coast Tropical TX UPCs 73296608113; 73296600558; 73296610927; 73296600559; 732966107055; 02060042710
Coast Citrus Distributors
FDA FoodClass I
Jalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged in assorted bulk package sizes (10lbs, 40lbs, 35lbs, 20lbs, 38lbs 1 1/9 Bushel) ; Product of MX; Coast Tropical TX UPCs 73296608113; 73296600558; 73296610927; 73296600559; 732966107055; 02060042710
Potential Salmonella Javiana contamination
Aug 26, 2026Coast Citrus Distributors
PharmaceuticalFDA Drugs
FDA DrugsniCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
American Regent, Inc.
FDA DrugsClass II
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
Food & BeverageFDA Food
FDA FoodWhole Foods Salsa, Heirloom Tomato. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Salsa, Heirloom Tomato. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
Medical DeviceFDA Devices
FDA DevicesCardiac Workstation 7000. Product Number: 860441.
Philips North America Llc
FDA DevicesClass II
Cardiac Workstation 7000. Product Number: 860441.
Device will intermittently provide inaccurate data related to native heart rate.
Aug 26, 2026Philips North America Llc
Food & BeverageFDA Food
FDA FoodVITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLIC
Lidl US TRADING
FDA FoodClass I
VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLIC
Salmonella. The firm received a positive test result of Salmonella in the product.
Aug 26, 2026Lidl US TRADING
Food & BeverageFDA Food
FDA FoodWhole Foods Trio Dip, Contains Pico de Gallo, Guacamole, Salsa. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 25926000000, 85001178876, 26383300000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Trio Dip, Contains Pico de Gallo, Guacamole, Salsa. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 25926000000, 85001178876, 26383300000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
Food & BeverageFDA Food
FDA FoodWhole Foods Roasted Corn Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 27132500000, 24075300000, 29956000000, 29533500000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Roasted Corn Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 27132500000, 24075300000, 29956000000, 29533500000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
PharmaceuticalFDA Drugs
FDA DrugsPEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Shilpa Medicare Limited
FDA DrugsClass II
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Aug 26, 2026Shilpa Medicare Limited
Food & BeverageFDA Food
FDA FoodWhole Foods Mild Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Mild Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP