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

22751–22775 of 27699

HighFDA (Devices)·Z-2787-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2797-2015·2015-09-30
Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening
Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.
Product
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2789-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2786-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2792-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2015·2015-09-30
Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk
Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.
Product
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2793-2015·2015-09-30
Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects
Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.
Product
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with…
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-2731-2015·2015-09-23
SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.
Product
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2770-2015·2015-09-23
Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation
Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.
Product
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2769-2015·2015-09-23
Applied Medical Resources Recalls Voyant Open Fusion Devices
Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.
Product
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2762-2015·2015-09-23
Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
Product
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2777-2015·2015-09-23
Medtronic CryoConsole Recalled Due to USB Component Issue
Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.
Product
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2767-2015·2015-09-23
Nico Myriad Console Recalled for Potential Cable Malfunction
Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.
Product
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2761-2015·2015-09-23
Medivators Recalls Hemocor HPH700 Hemoconcentrators Due to Low Ultrafiltration Performance
Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.
Product
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2771-2015·2015-09-23
Sony Medical Monitors Recalled for Failure to Power On or Display Image
Sony Medical Systems is recalling 4,952 medical monitors that may fail to turn on or lose image during clinical use.
Product
Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2775-2015·2015-09-23
Bayer Medrad Mark 7 Arterion Injection System Software Recall
Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.
Product
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2772-2015·2015-09-23
Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2782-2015·2015-09-23
Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage
Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.
Product
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2784-2015·2015-09-23
St Jude Merlin@home Transmitter Recalled for Backup VVI Operation
St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.
Product
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2766-2015·2015-09-23
Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk
Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.
Product
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2781-2015·2015-09-23
Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap
Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.
Product
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2485-2015·2015-09-16
Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures
Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.
Product
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2754-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers
Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. 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 physicians in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2484-2015·2015-09-16
Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures
Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.
Product
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2750-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments
Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by…
Category
Medical Device
Distribution
Distributed nationwide

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22751–22775 of 27699