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

26926–26950 of 40233

SevereFDA (Devices)·Z-1879-2017·2017-05-03
Arrow International Recalls Central Venous Catheter Kits Due to Hub Voids
Arrow International is recalling 310 units of Arrowg+ard Blue Plus Central Venous Catheterization Kits due to possible voids in the catheter hub that could lead to interlumen crossover.
Product
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1538-2017·2017-05-03
Heartware Recalls HVAD System Controllers for Exchange
Heartware is recalling all HVAD System Controllers currently on the market to exchange them for the next generation HVAD Controller (Controller 2.0).
Product
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System…
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-1888-2017·2017-05-03
Remel Blood Agar Plates Recalled for Listeria Contamination
Remel Inc is recalling Blood Agar plates due to confirmed surface contamination with Listeria monocytogenes. The products were distributed nationwide and in Puerto Rico.
Product
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1882-2017·2017-05-03
Savaria Stairfriend Stair Lifts Recalled for Welding Defect
Savaria Concord Lifts is recalling 226 Stairfriend stair lifts due to poor quality welding on the seat post.
Product
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1877-2017·2017-05-03
Cardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error
Cardiovascular Systems Inc is recalling 595 units of ViperWire Advance guide wires because 0.018-inch products were packaged as 0.014-inch.
Product
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2017·2017-05-03
Ulrich Medical Recalls uNion Cervical Plate System for Screw Mechanism Defect
Ulrich Medical USA Inc is recalling 4,854 uNion Cervical Plate Systems because static plate screws may disassociate. The recall covers devices distributed in 20 US states.
Product
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2017·2017-05-03
Merit Medical Recalls 1 mL Medallion Syringes Due to Plunger Tip Defect
Merit Medical Systems is voluntarily recalling 1 mL Medallion Syringes because of a defect in the syringe plunger tip.
Product
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2017·2017-05-03
CareFusion Recalls SmartSite Add-On Bag Access Device Due to Leakage
CareFusion is recalling 384,923 units of the SmartSite Add-On Bag Access Device because the spike port may separate or leak, potentially interrupting medication infusion.
Product
SmartSite Add-On Bag Access Device, Model No. 10013365
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1884-2017·2017-05-03
XTANT Medical Recalls 5.5mm CoCr Straight Rods Due to Labeling Error
XTANT Medical Inc. is recalling 97 units of 5.5mm CoCr Straight Rods because the labels may incorrectly identify the material as Ti6Al-4V ELI instead of Cobalt Chromium.
Product
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1887-2017·2017-05-03
Ortho VITROS VANC Reagent Recalled for Potential Biased Test Results
Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.
Product
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1885-2017·2017-05-03
Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery
Amendia is recalling 15 units of K-Wires labeled as stainless steel but made of nitinol. The wires were distributed to Georgia, Kansas, and Texas.
Product
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1875-2017·2017-05-03
Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects
Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.
Product
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1881-2017·2017-05-03
Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash
Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1886-2017·2017-05-03
Stryker SmartLife Large Aseptic Housing Recall for Weld Separation
Stryker is recalling 302 SmartLife Large Aseptic Housings due to complaints of housing deterioration and weld separation caused by improper cleaning practices.
Product
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1876-2017·2017-05-03
Becton Dickinson Recalls Trypticase Soy Agar and Chocolate Agar I-Plates
Becton Dickinson is recalling one lot of Trypticase Soy Agar and Chocolate Agar I-Plates because they may fail to recover specific Haemophilus organisms.
Product
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1821-2017·2017-04-26
Philips UNIQ X-ray Systems Recalled for Potential Fire Hazard
Philips is recalling UNIQ X-ray systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.
Product
UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1839-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1844-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1843-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1838-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1842-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills due to a potential for the cutting blade to detach or the drill head to fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1840-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1820-2017·2017-04-26
Philips Recalls Allura Xper Systems Due to Chiller Leak Fire Risk
Philips is recalling specific Allura Xper medical imaging systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.
Product
Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1846-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1851-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide

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26926–26950 of 40233