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

18701–18725 of 27647

HighFDA (Devices)·Z-0688-2018·2018-02-28
Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers
Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Product
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0682-2018·2018-02-28
Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns
Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.
Product
3-Way Standardbore Stopcock. Product Code: AMS-100.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2018·2018-02-28
Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach
Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.
Product
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2018·2018-02-28
Med Tec Protura Software Recalled for Pedestal Coordinate Errors
Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.
Product
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0650-2018·2018-02-28
Arrow International Recalls Multi Lumen Central Venous Catheterization Kits
Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Product
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2018·2018-02-28
Arrow International Recalls Multi Lumen Central Venous Catheterization Kits
Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Product
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2018·2018-02-28
Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws
Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.
Product
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0636-2018·2018-02-28
FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure
The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0646-2018·2018-02-28
Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach
Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.
Product
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0637-2018·2018-02-28
DeRoyal recalls custom sterile surgical packs with Terumo valve defect
DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.
Product
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0685-2018·2018-02-28
Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect
Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.
Product
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2018·2018-02-28
Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect
Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.
Product
Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0675-2018·2018-02-28
Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk
Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.
Product
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0662-2018·2018-02-28
Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error
Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.
Product
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0690-2018·2018-02-28
Arrow International Recalls PICC Powered by VPS Stylet Kits
Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.
Product
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0669-2018·2018-02-28
Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues
Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.
Product
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0643-2018·2018-02-28
Pentax Video Duodenoscope Recalled to Mitigate Infection Risk
Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.
Product
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0672-2018·2018-02-28
Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk
Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.
Product
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0687-2018·2018-02-28
Cosman Medical Recalls Nitinol TC Reusable Electrodes Due to Epoxy Damage
Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.
Product
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0657-2018·2018-02-28
Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide
Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.
Product
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0607-2018·2018-02-21
Sanofi Genzyme Recalls Synvisc-One Injections Due to Bacterial Contamination
Sanofi Genzyme is recalling Synvisc-One injections due to contamination with Methylbacterium thiocyanatum. The recall affects 12,380 units distributed in 36 states.
Product
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2018·2018-02-21
Graham Medical SnugFit Mattress Cover Recalled for Potential Tearing
Little Rapids Corporation is recalling Graham Medical SnugFit Expandable Mattress Covers because material defects may cause the cover to tear during lifting, posing a fall risk.
Product
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0565-2018·2018-02-21
C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures
C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.
Product
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0563-2018·2018-02-21
Kalila Medical Recalls Vado Steerable Sheaths Due to Torn Liner
Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.
Product
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0577-2018·2018-02-21
Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization
Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.
Product
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Category
Medical Device
Distribution
0 states

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18701–18725 of 27647