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

33176–33200 of 40449

ModerateFDA (Devices)·Z-1538-2015·2015-05-06
Coloplast Genesis Malleable Penile Prosthesis Mislabeled Size Recall
Coloplast is recalling 11 units of the 9.5 mm Genesis Malleable Penile Prosthesis because the retail box and patient labels incorrectly state the size as 9 mm.
Product
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1525-2015·2015-05-06
Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue
Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.
Product
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1534-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1532-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1524-2015·2015-05-06
Beckman Coulter Recalls MicroScan Pos Combo 33 Panels Due to Missing Desiccants
Beckman Coulter is recalling 664 boxes of MicroScan Pos Combo 33 panels because some were packaged without desiccants, which may cause substrate deterioration.
Product
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2015·2015-05-06
Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots
Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.
Product
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1540-2015·2015-05-06
Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling FAR-Infrared Heat Home Saunas because they were distributed without FDA 510(k) approval.
Product
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1544-2015·2015-05-06
Integra Tuohy Needles Recalled for Incorrect Length Labeling
Integra LifeSciences is recalling 90 Tuohy needles that were incorrectly labeled as 5 inches when they are actually 3.5 inches.
Product
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1550-2015·2015-05-06
Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.
Product
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1541-2015·2015-05-06
Therasage Portable FAR Infrared Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling 8 portable FAR infrared saunas because they were distributed without FDA 510(k) approval.
Product
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1522-2015·2015-05-06
Beckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34
Beckman Coulter is recalling 681 boxes of MicroScan Neg Breakpoint Combo Panel Type 34 due to reported panel degradation.
Product
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1558-2015·2015-05-06
Teleflex Medical Recalls Hudson RCI ConchaTherm Neptune Heated Humidifiers
Teleflex Medical is recalling 7,228 Hudson RCI ConchaTherm Neptune Heated Humidifiers because customer complaints reported the power ceasing and the display going blank.
Product
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1545-2015·2015-05-06
Incisive Surgical Recalls Insorb Subcuticular Skin Staplers Due to Labeling Error
Incisive Surgical Inc is recalling Insorb Subcuticular Skin Staplers in Turkey because a distributor over-labeled a portion of the lot with an incorrect expiration date.
Product
Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1531-2015·2015-05-06
Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation
Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1549-2015·2015-05-06
Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.
Product
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1533-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1537-2015·2015-05-06
GA Industries Recalls Logicon Caries Detector for Lack of FDA Approval
GA Industries is recalling the Logicon Caries Detector software because it was released without FDA approval.
Product
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1462-2015·2015-04-29
Laax Recalls TIGERPAW System II Implantable Occlusion Fasteners
Laax, Inc. is recalling TIGERPAW System II implantable fasteners due to reports of tissue tearing and bleeding during use.
Product
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1498-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 100 units of Crosscheck Plating Systems because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1456-2015·2015-04-29
OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk
OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, posing a risk of blood loss.
Product
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1461-2015·2015-04-29
Laax TigerPaw System II Implantable Occlusion Fastener Recalled for Tissue Tearing
Laax, Inc. is recalling the TigerPaw System II implantable occlusion fastener due to field reports of possible tissue tearing and bleeding during use.
Product
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1513-2015·2015-04-29
CSA Medical truFreeze Console Cryosurgical Unit Recalled for Excess Liquid Nitrogen Delivery
CSA Medical is recalling 82 truFreeze Console cryosurgical units because they may deliver excessive liquid nitrogen, posing risks of stricture, scarring, bradycardia, or pneumothorax.
Product
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1492-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Spec Deviations
Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1457-2015·2015-04-29
Siemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.
Product
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1494-2015·2015-04-29
Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Product
CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
Category
Medical Device
Distribution
Distributed nationwide

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33176–33200 of 40449