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

24226–24250 of 27699

HighFDA (Devices)·Z-0506-2015·2014-12-10
Alcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris
Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.
Product
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0496-2015·2014-12-10
Cure Medical Recalls Pediatric Urinary Catheters Due to Labeling Error
Cure Medical is recalling pediatric urinary catheters because some boxes are mislabeled as size 8 but contain size 10 catheters, posing a risk of injury.
Product
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0492-2015·2014-12-10
Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns
Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.
Product
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0491-2015·2014-12-10
Integra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage
Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.
Product
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0472-2015·2014-12-03
Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results
Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.
Product
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0206-2015·2014-12-03
Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold
Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.
Product
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0226-2015·2014-12-03
Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws
Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.
Product
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0474-2015·2014-12-03
Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors
Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.
Product
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2015·2014-12-03
Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0468-2015·2014-12-03
Summit J700 X-Ray Tube Stand Recalled for Insufficient Welds
Summit Industries is recalling 32 J700 Floor Mounted Tube Stands because insufficient welds may cause breakage, leading to equipment damage or injury.
Product
The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system)…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0428-2015·2014-12-03
Intuitive Surgical Recalls 8mm Large Needle Driver Instruments
Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.
Product
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0427-2015·2014-12-03
Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0447-2015·2014-12-03
Intuitive Surgical Recalls 8mm Curved Bipolar Dissectors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0429-2015·2014-12-03
Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0485-2015·2014-12-03
Respironics Esprit V1000 Ventilator Recall for Power Supply Defect
Respironics is recalling Esprit V1000 and V200 Conversion Ventilators because incorrect screw installation may cause a short circuit, preventing the switch to battery power during AC outages.
Product
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2015·2014-12-03
Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results
Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.
Product
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2015·2014-12-03
Vision RT AlignRT System Recalled for Potential Interlock Failure
Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.
Product
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0422-2015·2014-12-03
Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.
Product
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0441-2015·2014-12-03
Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices
Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.
Product
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0419-2015·2014-12-03
Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise
Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.
Product
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0432-2015·2014-12-03
Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0439-2015·2014-12-03
Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0442-2015·2014-12-03
Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0443-2015·2014-12-03
Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues
Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0446-2015·2014-12-03
Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states

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24226–24250 of 27699