DeRoyal Industries Inc: 226 FDA recall reports
Every medical device recall the FDA has published for DeRoyal Industries Inc. The fault, and how the agency graded it.
226Reports
4Class I
175Ongoing
2026-06-10Most recent
4 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.
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Z-2305-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Sterile wound dressing, lacks sterility assurance
- Product
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Where it went
- US Nationwide distribution in the states of FL & NC.
- How much
- 800 units
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoya
Z-1291-2025 · Class II · reported 2025-03-12 · Ongoing
- Why it was recalled
- Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
- Product
- DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
- Where it went
- U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
- How much
- 714 cases
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is inten
Z-1174-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
- Product
- DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
- Where it went
- U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI, O.U.S.: Kuwait
- How much
- 224,770 tubes/connectors
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Z-0309-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- Product
- DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
- Where it went
- US Nationwide distribution in the state of OH.
- How much
- 95 units
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Z-0308-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- Product
- DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- Where it went
- US Nationwide distribution in the state of OH.
- How much
- 384 units
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Z-0307-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- Product
- DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Where it went
- US Nationwide distribution in the state of OH.
- How much
- 160 units
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Z-0306-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- Product
- DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
- Where it went
- US Nationwide distribution in the state of OH.
- How much
- 780 units
Class I
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRA
Z-1382-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- Product
- GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
- Where it went
- Florida
- How much
- 134 tracecarts
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Z-0622-2024 · Class II · reported 2024-01-03 · Ongoing
- Why it was recalled
- Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- Product
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Where it went
- US: Virginia
- How much
- 252 units
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Z-0116-2024 · Class II · reported 2023-10-25 · Ongoing
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
- Product
- DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
- Where it went
- Pennsylvania
- How much
- 32 kits
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAP
Z-2090-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Product
- Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
- Where it went
- US Nationwide distribution.
- How much
- 306 packs
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK
Z-2086-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Product
- Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292
- Where it went
- US Nationwide distribution.
- How much
- 4225 packs
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Z-2087-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Product
- Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
- Where it went
- US Nationwide distribution.
- How much
- 40 units
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Z-2089-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Product
- Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- Where it went
- US Nationwide distribution.
- How much
- 3 packs
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, R
Z-2088-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Product
- Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
- Where it went
- US Nationwide distribution.
- How much
- 328 packs
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical
Z-1692-2023 · Class II · reported 2023-06-14 · Ongoing
- Why it was recalled
- The custom procedure packs contain light handle covers that have been recalled by another firm.
- Product
- Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
- Where it went
- US Nationwide distribution in the state of VA.
- How much
- 23 cases (52 packs)
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2)
Z-1691-2023 · Class II · reported 2023-06-14 · Ongoing
- Why it was recalled
- The custom procedure packs contain light handle covers that have been recalled by another firm.
- Product
- Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial...
- Where it went
- US Nationwide distribution in the state of VA.
- How much
- 1,391 cases (2,972 packs)
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Z-1283-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
- Product
- DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
- Where it went
- US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
- How much
- 27,200 devices
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Z-0927-2023 · Class II · reported 2023-01-18 · Terminated
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
- Product
- DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
- Where it went
- US Nationwide distribution in the states of IL, MO.
- How much
- 157 packs
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Z-0906-2023 · Class II · reported 2023-01-11 · Terminated
- Why it was recalled
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
- Product
- DeRoyal Tonsillectomy Tray, REF 89-10698.01
- Where it went
- Distribution in US states of VA, and SC.
- How much
- 320 units
DeRoyal MYELOGRAM PACK, REF 89-9304.05
Z-0647-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal MYELOGRAM PACK, REF 89-9304.05
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 2280 kits
DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
Z-0659-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 360 kits
DeRoyal VIT RD PACK 86ST, REF 89-7308.09
Z-0593-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal VIT RD PACK 86ST, REF 89-7308.09
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 16 kits
DeRoyal FOOT PACK, REF 89-9252.08
Z-0640-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal FOOT PACK, REF 89-9252.08
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 105 kits
DeRoyal PAIN TRAY, REF 89-10464.03
Z-0688-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal PAIN TRAY, REF 89-10464.03
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 150 Kits
DeRoyal SHOULDER KIT, REF 89-9497.08
Z-0655-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal SHOULDER KIT, REF 89-9497.08
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 14 kits
DeRoyal CANNULTED HIP PACK, REF 89-6977.10
Z-0582-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal CANNULTED HIP PACK, REF 89-6977.10
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 36 kits
DeRoyal TRANS CANAL PACK, REF 89-7157.12
Z-0587-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal TRANS CANAL PACK, REF 89-7157.12
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 156 kits
DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
Z-0668-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- XXX
- Product
- DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 35 kits
DeRoyal CATARACT PACK CSM, REF 89-6863
Z-0580-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
- Product
- DeRoyal CATARACT PACK CSM, REF 89-6863
- Where it went
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- How much
- 1220 kits
Showing the 30 most recent of 226. 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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