thejoe Winco Mfg., LLC

Winco Mfg., LLC: 26 FDA recall reports

Every medical device recall the FDA has published for Winco Mfg., LLC. The fault, and how the agency graded it.

26Reports

0Class I

0Ongoing

2016-10-19Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	26

By year reported

Year	Reports
2012	2
2013	4
2014	4
2015	13
2016	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provid

Z-0064-2017 · Class II · reported 2016-10-19 · Terminated

Why it was recalled: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Product: TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Where it went: Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
How much: 264 Stretcher Chairs

TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a

Z-0065-2017 · Class II · reported 2016-10-19 · Terminated

Why it was recalled: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Product: TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Where it went: Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
How much: 264 Stretcher Chairs

TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver

Z-0066-2017 · Class II · reported 2016-10-19 · Terminated

Why it was recalled: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Product: TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Where it went: Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
How much: 264 Stretcher Chairs

Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physicia

Z-2392-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chair

Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis

Z-2395-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 30 chairs

Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis

Z-2396-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chairs

Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geri

Z-2391-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chair

Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery

Z-2400-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 32 chairs

Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Phys

Z-2394-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 4 chairs

Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dial

Z-2399-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chairs

Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (L

Z-2403-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chairs

Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Phys

Z-2393-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 1 chair

Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendel

Z-2402-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 29 chairs

Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis

Z-2397-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 3 chairs

Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery,

Z-2401-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 27 chairs

Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Phy

Z-2398-2015 · Class II · reported 2015-08-26 · Terminated

Why it was recalled: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Product: Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Where it went: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
How much: 2 chairs

PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully uph

Z-1114-2014 · Class II · reported 2014-03-05 · Terminated

Why it was recalled: A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Product: PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
Where it went: Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
How much: 369 units (all models)

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side

Z-1117-2014 · Class II · reported 2014-03-05 · Terminated

Why it was recalled: A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Product: XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
Where it went: Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
How much: 369 units (all models)

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-gr

Z-1115-2014 · Class II · reported 2014-03-05 · Terminated

Why it was recalled: A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Product: CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
Where it went: Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
How much: 369 units (all models)

DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-

Z-1116-2014 · Class II · reported 2014-03-05 · Terminated

Why it was recalled: A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Product: DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
Where it went: Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
How much: 369 units (all models)

PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A mult

Z-0778-2013 · Class II · reported 2013-02-13 · Terminated

Why it was recalled: The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Product: PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Where it went: Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
How much: 95 units (All models)

Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A mult

Z-0779-2013 · Class II · reported 2013-02-13 · Terminated

Why it was recalled: The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Product: Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Where it went: Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
How much: 95 units (All models)

Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A m

Z-0780-2013 · Class II · reported 2013-02-13 · Terminated

Why it was recalled: The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Product: Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Where it went: Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
How much: 95 units (All models)

PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi po

Z-0777-2013 · Class II · reported 2013-02-13 · Terminated

Why it was recalled: The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Product: PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Where it went: Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
How much: 95 units (all models)

Caremor Cliner"Manufactured By WincoOcala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101

Z-0031-2013 · Class II · reported 2012-10-17 · Terminated

Why it was recalled: Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Product: Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Where it went: Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia
How much: 23 chairs

Caremor Cliner is labeled in part: "Manufactured By WincoOcala, FL 34474 www.wincomfg.com***Model No. 5

Z-0032-2013 · Class II · reported 2012-10-17 · Terminated

Why it was recalled: Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Product: Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Where it went: Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia
How much: 20 chairs

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All device recalls