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

4176–4200 of 5038

SevereFDA (Devices)·Z-1641-2015·2015-05-27
Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect
Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.
Product
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1643-2015·2015-05-27
Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation
Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.
Product
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualif
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1623-2015·2015-05-27
GE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts
GE Healthcare is recalling four CT scanners because over-torqued bolts could cause a component to detach, posing a risk of serious bodily injury.
Product
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1606-2015·2015-05-20
GE Healthcare Recalls CARESCAPE Bx50 Monitors for Pacemaker Detection Defect
GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.
Product
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1604-2015·2015-05-20
HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk
HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.
Product
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit sid
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1580-2015·2015-05-13
ViewRay Radiation Therapy System Recalled for Coordinate Correction Error
Viewray Incorporated is recalling one ViewRay System due to a software error affecting coordinate correction for non-standard patient positions.
Product
ViewRay System, Radiation Therapy System
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1536-2015·2015-05-06
Baxter Patient Control Modules Recalled for Potential Malfunction
Baxter Healthcare is recalling 7,596 Patient Control Modules due to a potential malfunction that could cause medication to flow when it should not.
Product
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1462-2015·2015-04-29
Laax Recalls TIGERPAW System II Implantable Occlusion Fasteners
Laax, Inc. is recalling TIGERPAW System II implantable fasteners due to reports of tissue tearing and bleeding during use.
Product
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1457-2015·2015-04-29
Siemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.
Product
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1513-2015·2015-04-29
CSA Medical truFreeze Console Cryosurgical Unit Recalled for Excess Liquid Nitrogen Delivery
CSA Medical is recalling 82 truFreeze Console cryosurgical units because they may deliver excessive liquid nitrogen, posing risks of stricture, scarring, bradycardia, or pneumothorax.
Product
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1492-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Spec Deviations
Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1494-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1461-2015·2015-04-29
Laax TigerPaw System II Implantable Occlusion Fastener Recalled for Tissue Tearing
Laax, Inc. is recalling the TigerPaw System II implantable occlusion fastener due to field reports of possible tissue tearing and bleeding during use.
Product
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1456-2015·2015-04-29
OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk
OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, posing a risk of blood loss.
Product
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1498-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 100 units of Crosscheck Plating Systems because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1377-2015·2015-04-15
Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent
Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.
Product
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1331-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1329-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1404-2015·2015-04-15
Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems
Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.
Product
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-1355-2015·2015-04-08
Boston Scientific Recalls Biliary Drainage Catheters Due to Fragmentation Risk
Boston Scientific is recalling specific lots of Expel Drainage Catheters because they may fragment after implantation, potentially requiring additional medical procedures to remove the pieces.
Product
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1362-2015·2015-04-08
Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures
Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.
Product
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and hu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1370-2015·2015-04-08
BD FACSCalibur Instruments Recalled for Incorrect Circuit Breaker Amperage
BD Biosciences is recalling 72 BD FACSCalibur instruments because some have circuit breakers with incorrect amperage ratings, which may fail to open during over-current situations.
Product
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1357-2015·2015-04-08
DePuy RECLAIM Hip Implant Inserter Adaptor Recalled for Fracture Risk
DePuy Orthopaedics is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor because the instrument may fracture during surgery, potentially leaving plastic pieces in the patient.
Product
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1356-2015·2015-04-08
Medtronic Temporary Pacemaker Recalled for Battery Connection Failure
Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.
Product
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1324-2015·2015-04-01
Titan Spine Recalls TCS Straight Hexalobe Drivers Due to Tip Shearing
Titan Spine, LLC is recalling 26 Endo TCS Driver Straight Hexalobe #6 units because the tips sheared off during use in patients with dense bones.
Product
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
Category
Medical Device
Distribution
18 states

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4176–4200 of 5038