thejoe AVID Medical, Inc.

AVID Medical, Inc.: 169 FDA recall reports

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

169Reports

17Class I

127Ongoing

2026-07-29Most recent

17 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	152
Class I	17

By year reported

Year	Reports
2016	4
2017	1
2018	24
2020	9
2021	4
2024	73
2025	34
2026	20

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.

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Z-2772-2026 · Class II · reported 2026-07-29 · Ongoing

Why it was recalled: Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Product: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Where it went: U.S. Nationwide distribution in the state of California.
How much: 112 kits

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Z-2763-2026 · Class II · reported 2026-07-29 · Ongoing

Why it was recalled: Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Product: Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Where it went: US Nationwide distribution in the state of California.
How much: 260 kits

Halyard, Towel Six Pack. Kit Code: AMTS70-01.

Z-2408-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Product: Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Where it went: US Nationwide distribution in the state of Iowa.
How much: 224 kits

Halyard, Pain Pack. Kit Code: AMPK48-01.

Z-2407-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Product: Halyard, Pain Pack. Kit Code: AMPK48-01.
Where it went: US Nationwide distribution in the state of Iowa.
How much: 120 kits

Halyard, Drape Pack. Kit Code: LMDP36-01.

Z-2409-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Product: Halyard, Drape Pack. Kit Code: LMDP36-01.
Where it went: US Nationwide distribution in the state of Iowa.
How much: 72 kits

Halyard, Eye Bag Pack. Kit Code: UIEB48-01.

Z-2410-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Product: Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Where it went: US Nationwide distribution in the state of Iowa.
How much: 60 kits

Class I

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

Z-1972-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 6,956 kits

Class I

Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.

Z-1971-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 180 kits

Class I

Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

Z-1979-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 75 kits

Class I

Halyard CATH LAB kit. Model Number: SACL75-01.

Z-1974-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard CATH LAB kit. Model Number: SACL75-01.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 172 kits

Class I

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Z-1970-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 222 kits

Class I

Halyard CATH LAB kit. Model Number: SACL75AM.

Z-1973-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard CATH LAB kit. Model Number: SACL75AM.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 228 kits

Class I

Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

Z-1976-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 204 kits

Class I

Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Z-1975-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 2,932 kits

Class I

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

Z-1978-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 2,392 kits

Class I

Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

Z-1977-2026 · Class I · reported 2026-05-13 · Ongoing

Why it was recalled: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product: Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Where it went: US distribution to FL, IL, MO, MS, NC, NE, TX.
How much: 6,052 kits

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Z-1338-2026 · Class II · reported 2026-02-18 · Ongoing

Why it was recalled: Tyvek bag seal issue which may compromise sterility of the kit.
Product: Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Where it went: US Nationwide distribution in the states of New Jersey.
How much: 1,500 units

Class I

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

Z-1001-2026 · Class I · reported 2026-01-14 · Ongoing

Why it was recalled: Devices are not suitable for organ transplant.
Product: Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Where it went: US Nationwide distribution in the states of FL, GA and Puerto Rico.
How much: 52 units

Class I

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

Z-1000-2026 · Class I · reported 2026-01-14 · Ongoing

Why it was recalled: Devices are not suitable for organ transplant.
Product: Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Where it went: US Nationwide distribution in the states of FL, GA and Puerto Rico.
How much: 132 units

Class I

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

Z-1002-2026 · Class I · reported 2026-01-14 · Ongoing

Why it was recalled: Devices are not suitable for organ transplant.
Product: Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Where it went: US Nationwide distribution in the states of FL, GA and Puerto Rico.
How much: 380 units

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

Z-0928-2026 · Class II · reported 2025-12-24 · Ongoing

Why it was recalled: Potential for incomplete seal on header bag.
Product: Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Where it went: US distribution to GA, IL, NE, MD.
How much: 300 units

Halyard, EP LAB PK. Catalog Number: ESJH009-03.

Z-0927-2026 · Class II · reported 2025-12-24 · Ongoing

Why it was recalled: Potential for incomplete seal on header bag.
Product: Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Where it went: US distribution to GA, IL, NE, MD.
How much: 240 units

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

Z-0929-2026 · Class II · reported 2025-12-24 · Ongoing

Why it was recalled: Potential for incomplete seal on header bag.
Product: Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Where it went: US distribution to GA, IL, NE, MD.
How much: 90 units

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

Z-0930-2026 · Class II · reported 2025-12-24 · Ongoing

Why it was recalled: Potential for incomplete seal on header bag.
Product: Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Where it went: US distribution to GA, IL, NE, MD.
How much: 56 units

Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

Z-0926-2026 · Class II · reported 2025-12-24 · Ongoing

Why it was recalled: Potential for incomplete seal on header bag.
Product: Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Where it went: US distribution to GA, IL, NE, MD.
How much: 42 units

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

Z-2530-2025 · Class II · reported 2025-09-17 · Ongoing

Why it was recalled: Potential for open header bag seals, compromising sterility.
Product: Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Where it went: US Nationwide distribution in the state of Florida.
How much: 57 units

Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

Z-2531-2025 · Class II · reported 2025-09-17 · Ongoing

Why it was recalled: Potential for open header bag seals, compromising sterility.
Product: Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Where it went: US Nationwide distribution in the state of Florida.
How much: 228 units

GYN ROBOTIC PACK. Medical convenience kit.

Z-2251-2025 · Class II · reported 2025-08-13 · Ongoing

Why it was recalled: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Product: GYN ROBOTIC PACK. Medical convenience kit.
Where it went: Domestic: CA, IL, MD, OH, PA, TX, WA.
How much: 45 units

LAP CHOLE PACK. Medical convenience kit.

Z-2253-2025 · Class II · reported 2025-08-13 · Ongoing

Why it was recalled: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Product: LAP CHOLE PACK. Medical convenience kit.
Where it went: Domestic: CA, IL, MD, OH, PA, TX, WA.
How much: 85 units

PACK GENERAL ROBOTIC. Medical convenience kit.

Z-2259-2025 · Class II · reported 2025-08-13 · Ongoing

Why it was recalled: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Product: PACK GENERAL ROBOTIC. Medical convenience kit.
Where it went: Domestic: CA, IL, MD, OH, PA, TX, WA.
How much: 656 units

Showing the 30 most recent of 169. 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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