Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

22726–22750 of 27663

SevereFDA (Devices)·Z-2754-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers
Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2484-2015·2015-09-16
Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures
Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.
Product
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2750-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments
Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2752-2015·2015-09-16
Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System
Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2742-2015·2015-09-16
Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings
Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.
Product
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2746-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled
Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2735-2015·2015-09-16
Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance
Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.
Product
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2758-2015·2015-09-16
Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System
Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2753-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers
Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.
Product
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2757-2015·2015-09-16
Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System
Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2751-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers
Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.
Product
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2745-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall
Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2741-2015·2015-09-16
Siemens Recalls Dimension CREA Tests for Falsely Depressed Results
Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.
Product
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2747-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall
Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2738-2015·2015-09-16
Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions
Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.
Product
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2748-2015·2015-09-16
Elcam Medical stopcock recall due to punctured blister packages
Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.
Product
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2755-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Crocodile Graspers
Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.
Product
Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2756-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Maryland Bipolar Forceps
Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2560-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2558-2015·2015-09-09
Customed Cysto TUR Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.
Product
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2676-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2697-2015·2015-09-09
Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2545-2015·2015-09-09
MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.
Product
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2707-2015·2015-09-09
Customed Cesarean PK 4/CS Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2527-2015·2015-09-09
Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide

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