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

37126–37150 of 40449

ModerateFDA (Devices)·Z-0338-2014·2013-11-27
Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues
Synovis is recalling Vascu Guard and Dura-Guard patches because specific fluid ounce units shipped in divided cell configurations with a specific revision of the Instructions for Use.
Product
Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0296-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS ALKP Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS ALKP Slides because of slide dispense issues. The recall affects 183,267 units distributed worldwide.
Product
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0355-2014·2013-11-27
Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration
Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.
Product
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0331-2014·2013-11-27
ConMed Altrus Thermal Tissue Fusion Handpieces Recalled for Particulate Matter
ConMed is recalling 65 Altrus Thermal Tissue Fusion handpieces exposed to excessive particulate matter during manufacture, which could cause minor local infections.
Product
ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0369-2014·2013-11-27
Synthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades
Synthes USA is recalling Titanium Trochanteric Fixation Nail (TFN) Helical Blades due to a potential for non-conforming products to be distributed.
Product
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0295-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product ALC Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides due to slide dispense issues affecting the cartridges used with the product.
Product
VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0321-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.
Product
VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0319-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 6,606 units distributed worldwide.
Product
VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0313-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Fe Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Fe Slides due to slide dispense issues. The recall affects 37,525 units distributed worldwide.
Product
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0318-2014·2013-11-27
Ortho-Clinical Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.
Product
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0372-2014·2013-11-27
Hospira Recalls Symbiq Infuser Batteries Due to Incorrect Model Shipment
Hospira is recalling 59 Symbiq infuser batteries because the wrong model (E10) was shipped instead of the correct E09 model.
Product
*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0360-2014·2013-11-27
Salter Labs Recalls CO2 Sample Lines Due to Incorrect Length
Salter Labs is recalling specific lots of 15-foot CO2 sample lines because they may contain 30-foot tubes instead.
Product
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0325-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.
Product
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0323-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS SALI Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS SALI Slides because the associated Slide Dispense cartridges have slide dispense issues.
Product
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0292-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS ACET Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ACET Slides because of slide dispense issues. The recall affects 16,732 units distributed worldwide.
Product
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0308-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry CREA Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides due to slide dispense issues. The recall affects 364,752 units distributed worldwide.
Product
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0297-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 units distributed worldwide.
Product
VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0347-2014·2013-11-27
Riverpoint Recalls Vilet Surgical Suture Due to Labeling Error
Riverpoint Medical is recalling 1,932 pieces of Vilet surgical suture because the label incorrectly states the suture is undyed when it is actually violet.
Product
Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0302-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.
Product
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0353-2014·2013-11-27
Restoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration
Restoration Robotics is recalling Epsilon Skin Tensioner devices because stainless steel pins may have discoloration from insufficient cleaning during passivation.
Product
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0336-2014·2013-11-27
Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts
Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.
Product
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0357-2014·2013-11-27
Zimmer Trinica Anterior Lumbar Plate Instrument Tray Recall for Sterilization Issues
Zimmer Spine is recalling Trinica ALP Instrument Trays because ratchet handles may not sterilize effectively due to tray design interference.
Product
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0337-2014·2013-11-27
GE Healthcare Recalls Centricity Perinatal and Intensive Care Software
GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.
Product
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0376-2014·2013-11-27
Ivoclar Vivadent Recalls ExciTE F DSC Dental Adhesive Due to Discoloration
Ivoclar Vivadent is recalling ExciTE F DSC Dental Adhesive because it produces blue-green discoloration when used with cements.
Product
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0311-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.
Product
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide

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37126–37150 of 40449