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

31876–31900 of 40325

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
ModerateFDA (Devices)·Z-2749-2015·2015-09-16
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging
Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.
Product
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2737-2015·2015-09-16
Mindray DPM 7 Patient Monitors Recalled for Black Screen Display
Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.
Product
Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2740-2015·2015-09-16
DermaPen Pro Micro Needling System Recalled for Lack of FDA Clearance
Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.
Product
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2744-2015·2015-09-16
Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall
Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.
Product
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2739-2015·2015-09-16
Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.
Product
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2736-2015·2015-09-16
Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance
Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.
Product
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2759-2015·2015-09-16
Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues
Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.
Product
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic…
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
SevereFDA (Devices)·Z-2546-2015·2015-09-09
MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Product
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2655-2015·2015-09-09
Customed Suction Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SUCTION CATHETER KIT CUSTOMED 50/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-2536-2015·2015-09-09
MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Product
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2534-2015·2015-09-09
Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2537-2015·2015-09-09
Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns
Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2535-2015·2015-09-09
MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2547-2015·2015-09-09
Physio-Control QuikCombo Pacing and Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien is recalling 56,000 sets of Physio-Control QuikCombo electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Product
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2488-2015·2015-09-09
Synthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.
Product
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2517-2015·2015-09-09
Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Product
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2710-2015·2015-09-09
Customed Curations Kits Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Product
CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state

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31876–31900 of 40325