C.R. Bard Inc: 117 FDA recall reports
Every medical device recall the FDA has published for C.R. Bard Inc. The fault, and how the agency graded it.
117Reports
5Class I
65Ongoing
2026-05-27Most recent
5 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
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.
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silas
Z-2226-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Due to stain present on the surface of affected foley catheters.
- Product
- Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
- Where it went
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI O.U.S.: Canada
- How much
- 106,160
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Z-0907-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Product
- BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
- How much
- 116 units
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Z-0905-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Product
- Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
- How much
- 116 units
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Z-0906-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Product
- BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
- How much
- 4350 units
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Z-0908-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Product
- BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
- How much
- 116 units
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Z-2589-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- Product
- SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
- Where it went
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- How much
- 4,300
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Z-2590-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- Product
- SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
- Where it went
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- How much
- 4,300
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Z-2591-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- Product
- SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
- Where it went
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- How much
- 3670
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Ba
Z-2462-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
- Product
- Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
- Where it went
- Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.
- How much
- 175,158
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Z-2076-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Cather packaging may contain the incorrect French size.
- Product
- REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
- How much
- 63 units
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 211
Z-2074-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Cather packaging may contain the incorrect French size.
- Product
- BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 02131
Z-2075-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Cather packaging may contain the incorrect French size.
- Product
- BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
Class I
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Z-1759-2025 · Class I · reported 2025-05-28 · Ongoing
- Why it was recalled
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Product
- Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
- Where it went
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
- How much
- N/A
Class I
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Z-1758-2025 · Class I · reported 2025-05-28 · Ongoing
- Why it was recalled
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Product
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
- Where it went
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
- How much
- N/A
Class I
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
Z-1757-2025 · Class I · reported 2025-05-28 · Ongoing
- Why it was recalled
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Product
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
- Where it went
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
- How much
- N/A
Class I
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm)
Z-1755-2025 · Class I · reported 2025-05-28 · Ongoing
- Why it was recalled
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Product
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
- Where it went
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
- How much
- N/A
Class I
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Z-1756-2025 · Class I · reported 2025-05-28 · Ongoing
- Why it was recalled
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Product
- Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
- Where it went
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
- How much
- N/A
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care
Z-2154-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
- Product
- Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
- Where it went
- Distribution was nationwide. There was no government/military/foreign distribution.
- How much
- 6,420 devices
Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
Z-0792-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
- Where it went
- US
- How much
- 17250 units
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
Z-0800-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
- Where it went
- US
- How much
- 57159 units
Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
Z-0794-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
- Where it went
- US
- How much
- 37059 units
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
Z-0798-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
- Where it went
- US
- How much
- 36440 units
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
Z-0803-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
- Where it went
- US
- How much
- 3650 units
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Z-0797-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
- Where it went
- US
- How much
- 26100 units
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
Z-0796-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
- Where it went
- US
- How much
- 6600 units
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
Z-0801-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
- Where it went
- US
- How much
- 187550 units
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF
Z-0805-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
- Where it went
- US
- How much
- 9860 units
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
Z-0799-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
- Where it went
- US
- How much
- 51750 units
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
Z-0795-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
- Where it went
- US
- How much
- 39430 units
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Z-0790-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Product
- Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
- Where it went
- US
- How much
- 3400 units
Showing the 30 most recent of 117. 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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