Luminex Corporation: 39 FDA recall reports
Every medical device recall the FDA has published for Luminex Corporation. The fault, and how the agency graded it.
39Reports
0Class I
27Ongoing
2025-06-11Most 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 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
By year reported
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.
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-res
Z-1903-2025 · Class II · reported 2025-06-11 · Completed
- Why it was recalled
- It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
- Product
- VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
- Where it went
- US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
- How much
- 89 units
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Z-2533-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
- Product
- Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Where it went
- US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
- How much
- 1,100 kits
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-01
Z-0500-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Potentially defective utility trays in the reagent kits.
- Product
- Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
- How much
- 222 kits (4,440 trays)
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Z-2024-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
- Product
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Where it went
- Worldwide and US Nationwide Distribution
- How much
- 114 units
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Z-2023-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
- Product
- Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- Where it went
- Worldwide and US Nationwide Distribution
- How much
- 3987 units
ARIES SARS-CoV-2 Assay, REF: 50-10047
Z-0134-2023 · Class II · reported 2022-11-02 · Ongoing
- Why it was recalled
- A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
- Product
- ARIES SARS-CoV-2 Assay, REF: 50-10047
- Where it went
- Distribution US nationwide, Indonesia, and Hong Kong.
- How much
- 5,141 (24 Cassettes)
ARIES SARS-CoV-2 Assay
Z-1524-2022 · Class II · reported 2022-08-24 · Ongoing
- Why it was recalled
- SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
- Product
- ARIES SARS-CoV-2 Assay
- Where it went
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- How much
- 257
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Z-1335-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
- Product
- VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
- Where it went
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- How much
- 5601 units
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Z-1334-2022 · Class II · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
- Product
- Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- Where it went
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- How much
- 296 units
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Z-1092-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
- Product
- Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- Where it went
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- How much
- 24 units
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Z-1109-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- Product
- VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
- Where it went
- US
- How much
- 984 units
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Z-0920-2022 · Class II · reported 2022-04-20 · Ongoing
- Why it was recalled
- Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
- Product
- Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- Where it went
- US: TX, CT, LA
- How much
- 4 units
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Z-0553-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
- Product
- ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
- How much
- 329
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Z-0498-2022 · Class II · reported 2022-01-26 · Terminated
- Why it was recalled
- Impacted lot may leak inside the ARIES instrument.
- Product
- ARIES HSV 1&2 Assay, Part Number/REF 50-10017
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
- How much
- 296 kits
Verigene EP Amplification Reagent Kit Test
Z-2451-2021 · Class II · reported 2021-09-22 · Ongoing
- Why it was recalled
- There is potential for false positive results.
- Product
- Verigene EP Amplification Reagent Kit Test
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
- How much
- 4579 kits
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Z-2006-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 38,990
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Z-2008-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 17,110
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Z-2009-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 24,338
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Z-2010-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 1,261
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Z-2011-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 165
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Z-2007-2021 · Class II · reported 2021-07-14 · Ongoing
- Why it was recalled
- Potential for a false-negative result.
- Product
- Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
- Where it went
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- How much
- 36,416
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold na
Z-1488-2021 · Class II · reported 2021-05-05 · Ongoing
- Why it was recalled
- Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
- Product
- VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
- Where it went
- Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.
- How much
- 1210 Units
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Posi
Z-0476-2021 · Class II · reported 2020-12-02 · Terminated
- Why it was recalled
- Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
- Product
- Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
- Where it went
- Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey
- How much
- 2838 units
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negat
Z-0477-2021 · Class II · reported 2020-12-02 · Terminated
- Why it was recalled
- Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
- Product
- Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
- Where it went
- Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey
- How much
- 2838 units
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identi
Z-0054-2021 · Class II · reported 2020-10-14 · Ongoing
- Why it was recalled
- No results/incorrect results due to failure of the hybridization heater.
- Product
- VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Where it went
- US distribution in MO. No OUS
- How much
- 1 system
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD -
Z-2776-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
- Product
- Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.
- How much
- Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD -
Z-2775-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
- Product
- Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.
- How much
- Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical la
Z-2292-2019 · Class II · reported 2019-08-28 · Terminated
- Why it was recalled
- An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
- Product
- Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
- Where it went
- Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom
- How much
- 153 (140 U.S. and 13 O.U.S.)
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Z-2283-2019 · Class II · reported 2019-08-21 · Ongoing
- Why it was recalled
- Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- Product
- ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
- Where it went
- US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
- How much
- N/A
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Z-2287-2019 · Class II · reported 2019-08-21 · Ongoing
- Why it was recalled
- Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
- Product
- ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
- Where it went
- US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
- How much
- N/A
Showing the 30 most recent of 39. The rest are searchable at the FDA enforcement report database.
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.
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