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 deaths or serious injuries are reported, 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

4001–4025 of 5111

SevereFDA (Devices)·Z-1641-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphy
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1639-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1666-2016·2016-05-18
Siemens Uric Acid Assays Recalled Due to Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.
Product
Dimension Vista Assays: Uric Acid (URCA)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1634-2016·2016-05-18
Stryker Recalls CinchLock SS Knotless Anchor Due to Wire Breakage
Stryker is recalling CinchLock SS Knotless Anchors after reports of internal wire breakage upon deployment.
Product
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2016·2016-05-18
Bradshaw Medical Recalls Axial Torque Limiting Drivers Due to Component Failure
Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.
Product
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise d
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1616-2016·2016-05-18
Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk
Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.
Product
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1632-2016·2016-05-18
St. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk
St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.
Product
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening v
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1648-2016·2016-05-18
Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure
Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.
Product
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1535-2016·2016-05-11
B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk
B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.
Product
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1531-2016·2016-05-11
B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk
B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.
Product
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health ce
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1612-2016·2016-05-11
Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure
Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.
Product
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life sup
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1536-2016·2016-05-11
B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk
B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.
Product
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis cen
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1580-2016·2016-05-04
Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking
Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.
Product
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Category
Medical Device
Distribution
30 states
SevereFDA (Food)·F-1250-2016·2016-05-04
Tarry Medical Recalls DandleLION Kisses Due to Microbial Contamination
Tarry Medical Products is recalling DandleLION Kisses sterile sucrose solution due to microbial contamination. The product is distributed in nine states.
Product
DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384
Category
Medical Device
Distribution
9 states
CriticalFDA (Devices)·Z-1529-2016·2016-04-27
Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard
Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.
Product
MEVION S250 for Proton Radiation Therapy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1551-2016·2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1530-2016·2016-04-27
Acorn 180 Curved Stairlift Recalled Due to Broken Rivets
Acorn Stairlifts Inc is recalling 1,290 Acorn 180 Curved Stairlifts in the US because aluminum rivets may break under prolonged use.
Product
Acorn 180 Curved Stairlift
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1453-2016·2016-04-20
Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues
Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Product
Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK 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-1393-2016·2016-04-20
RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk
RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.
Product
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1422-2016·2016-04-20
Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001402 PLASTIC SURGERY PACK 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-1481-2016·2016-04-20
Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK 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
CriticalFDA (Devices)·Z-1275-2016·2016-04-13
FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk
Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.
Product
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1323-2016·2016-04-13
MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking
MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.
Product
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1315-2016·2016-04-13
ScottCare TeleSentry Battery Recall Due to Explosion Risk During Recharging
ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.
Product
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient sympto
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-1327-2016·2016-04-13
Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect
Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.
Product
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
Category
Medical Device
Distribution
Distributed nationwide

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4001–4025 of 5111