thejoe Medtronic

Medtronic: 47 FDA recall reports

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

47Reports

1Class I

0Ongoing

2017-06-21Most recent

1 Class I on this page

Class 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	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	46
Class I	1

By year reported

Year	Reports
2016	34
2017	13

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.

SCHRITTMACHER ANGIO X3; Item Number: 4045255423347

Z-2548-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

CUSTOM SUTURE PACK; Item Number: US1540 and US1614

Z-2547-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M

Z-2544-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48"

Z-2543-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z23

Z-2545-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

USPACK-SUTURE KIT; Item Number: US1672

Z-2546-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: USPACK-SUTURE KIT; Item Number: US1672
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH;

Z-2542-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number:

Z-2541-2017 · Class II · reported 2017-06-21 · Terminated

Why it was recalled: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Product: Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number:...
Where it went: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
How much: 478,465 (total for all products)

BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

Z-1472-2017 · Class II · reported 2017-03-22 · Terminated

Why it was recalled: Handle may break during use.
Product: BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Where it went: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
How much: 1,096 Units (total for all products)

SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01

Z-1473-2017 · Class II · reported 2017-03-22 · Terminated

Why it was recalled: Handle may break during use.
Product: SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
Where it went: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
How much: 1,096 Units (total for all products)

SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01

Z-1474-2017 · Class II · reported 2017-03-22 · Terminated

Why it was recalled: Handle may break during use.
Product: SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
Where it went: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
How much: 1,096 Units (total for all products)

SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Z-1475-2017 · Class II · reported 2017-03-22 · Terminated

Why it was recalled: Handle may break during use.
Product: SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Where it went: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
How much: 1,096 Units (total for all products)

BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

Z-1476-2017 · Class II · reported 2017-03-22 · Terminated

Why it was recalled: Handle may break during use.
Product: BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
Where it went: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
How much: 1,096 Units (total for all products)

Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 I

Z-0890-2017 · Class II · reported 2016-12-28 · Terminated

Why it was recalled: Product sterility is compromised due to breach of the sterile barrier
Product: Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Where it went: Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
How much: 230 systems

Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic

Z-0889-2017 · Class II · reported 2016-12-28 · Terminated

Why it was recalled: Product sterility is compromised due to breach of the sterile barrier
Product: Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Where it went: Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
How much: 1,293,169 systems

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopi

Z-2555-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 19200

Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and

Z-2564-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 85630

Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab La

Z-2557-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 6769

Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and

Z-2566-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 24870

Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and

Z-2576-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 332

Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and

Z-2571-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: N/A

Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic

Z-2577-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 3470

Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic

Z-2575-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 50055

Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic H

Z-2574-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 63320

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic

Z-2554-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 13420

Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset a

Z-2563-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 6381

Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset a

Z-2562-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 161940

Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and

Z-2565-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 349629

Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparosco

Z-2572-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: 1440

Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset

Z-2569-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: Potential for compromise of the package resulting in a breach of the sterile barrier
Product: Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Where it went: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
How much: N/A

Showing the 30 most recent of 47. 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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