Hazard

Recalled Component recalls

26 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 26
Critical: 0
Severe: 0
Most recent: 2024-12-11

Of the 26 recalled component recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all recalled component recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 26

HighFDA (Devices)·Z-0638-2025·2024-12-11
MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0649-2025·2024-12-11
Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0634-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.
Product
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2023·2023-01-11
FDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes
Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.
Product
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0562-2023·2022-12-21
DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits distributed across 23 U.S. states.
Product
DeRoyal EYE PACK, REF 89-4051.09
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0684-2023·2022-12-21
DeRoyal Procedure Packs Recalled for Containing Recalled Steri Drapes
DeRoyal CRANI PACK procedure kits are being recalled because they contain 3M Health Care Steri Drapes that were previously recalled. Affected kits were distributed to medical facilities across multiple U.S. states.
Product
DeRoyal CRANI PACK, REF 89-10242.04
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0597-2023·2022-12-21
DeRoyal Spinal Fusion Packs Recalled for Containing Affected 3M Steri Drapes
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.
Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.13
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0570-2023·2022-12-21
GEO-MED Podiatry Pack Recalled Due to Previously Recalled Component
DeRoyal Industries is recalling 184 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states because they contain 3M Health Care Steri Drapes that were previously recalled. The affected kits have specific lot numbers with expirations through February 2025.
Product
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0596-2023·2022-12-21
DeRoyal Spinal Fusion Packs Recalled Due to Affected Sterile Drapes
DeRoyal Industries is recalling 27 kits of its Spinal Fusion Pack due to inclusion of recalled 3M Health Care Steri Drapes. The affected lots were distributed across 23 U.S. states.
Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.12
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0590-2023·2022-12-21
DeRoyal BASIC NEURO PACK kits recalled due to 3M Steri Drapes recall
DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.
Product
DeRoyal BASIC NEURO PACK, REF 89-7258.10
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0614-2023·2022-12-21
DeRoyal SPINE PACK procedure kits recalled due to included 3M Steri Drapes
DeRoyal Industries is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.
Product
DeRoyal SPINE PACK, REF 89-8361.09
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0615-2023·2022-12-21
DeRoyal SPINE PACK procedure kits recalled due to recalled Steri Drapes
DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.
Product
DeRoyal SPINE PACK, REF 89-8361.10
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0571-2023·2022-12-21
DeRoyal Ophtalmology Procedure Packs with Recalled Steri Drapes
DeRoyal Industries is recalling 90 ophtalmology procedure kits because they contain 3M Steri Drapes that have been recalled. The affected kits were distributed across multiple U.S. states.
Product
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0321-2023·2022-11-30
Regard SPINE Surgical Kits Recalled for Containing Unsafe Drapes
ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Product
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0285-2023·2022-11-30
Surgical Convenience Kits Recalled Due to Included Recalled Surgical Drapes
ROi CPS LLC is recalling 326 regard TOTAL JOINT surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that were previously recalled. No illnesses or injuries have been reported.
Product
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0301-2023·2022-11-30
Surgical kits recalled: Regard VITRECTOMY PK contained 3M recalled components
Regard VITRECTOMY PK surgical convenience kits are being recalled because they contain 3M surgical drapes that were separately recalled. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Product
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0312-2023·2022-11-30
Neurosurgery convenience kits recalled due to included recalled surgical drapes
ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.
Product
regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0283-2023·2022-11-30
Regard LAMINECTOMY surgical kits recalled due to recalled 3M drapes
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
Product
regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0294-2023·2022-11-30
Surgical Convenience Kits Recalled for Containing Recalled 3M Surgical Drapes
ROi CPS LLC is recalling 170 surgical convenience kits containing 3M surgical drapes that were previously recalled. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
Product
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0291-2023·2022-11-30
Surgical convenience kits recalled due to included recalled 3M drapes
Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
Product
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0319-2023·2022-11-30
Surgical Convenience Kits Recalled Due to Included 3M Surgical Drapes
ROi CPS LLC is recalling 54 regard LATERAL SHOULDER surgical convenience kits containing 3M surgical drapes that were subsequently recalled by the manufacturer. Affected kits were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.
Product
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0310-2023·2022-11-30
Surgical Convenience Kits Recalled for Included 3M Surgical Drapes
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
Product
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0320-2023·2022-11-30
Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
Product
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0306-2023·2022-11-30
Surgical Convenience Kits Containing Recalled 3M Surgical Drapes
Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.
Product
¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0286-2023·2022-11-30
Surgical Convenience Kits Recalled Due to Unsafe 3M Surgical Drapes
ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
Product
regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
Category
Medical Device
Distribution
4 states