The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1851–1875 of 3531

  • 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
    0 states
  • ModerateFDA (Devices)·Z-0631-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Surgical Pack Recall (Class II)

    DeRoyal Industries is recalling 180 kits of laminectomy spinal fusion surgical packs distributed across 23 states. The reason for recall is not specified in the available source.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0603-2023·2022-12-21

    DeRoyal EYE TRAY Procedure Packs Recalled Due to 3M Steri Drape Recall

    DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across multiple U.S. states.

    Product
    DeRoyal EYE TRAY PGYBK, REF 89-7978.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0660-2023·2022-12-21

    Medical Device Kit Recall — DeRoyal Abdominoplasty with Lipo Pack

    DeRoyal Industries is recalling 438 abdominoplasty kits distributed across 23 US states. The reason for the recall is not disclosed in available FDA documentation.

    Product
    DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0611-2023·2022-12-21

    Medical Device Recall: DeRoyal Podiatry Pack Kit (FDA Class II)

    DeRoyal Industries has initiated a voluntary recall of 186 DeRoyal Podiatry Pack kits (Lot 56705544, exp. 6/1/2026) distributed across 22 US states. The specific reason is not provided in the source documentation.

    Product
    DeRoyal PODIATRY PACK, REF 89-8359.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0702-2023·2022-12-21

    Medical Device Recall: DeRoyal NEURO SPINE BACK PACK Kit

    DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.

    Product
    DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0641-2023·2022-12-21

    DeRoyal NEURO PACK medical device recalled voluntarily by manufacturer

    DeRoyal Industries Inc initiated a voluntary recall of 93 kits of the DeRoyal NEURO PACK affecting 23 U.S. states. The recall affects three lot numbers with March 1, 2025 expiration.

    Product
    DeRoyal NEURO PACK, REF 89-9253.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0658-2023·2022-12-21

    DeRoyal TOTAL HIP KIT orthopedic prosthetic device recalled

    DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.

    Product
    DeRoyal TOTAL HIP KIT, REF 89-9498.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0709-2023·2022-12-21

    DeRoyal GEO-MED Cataract Pack Recalled Across Multiple US States

    DeRoyal Industries is voluntarily recalling 834 GEO-MED Cataract Pack kits (REF 89-5790.08) distributed across 23 US states. The FDA classified this as a Class II recall, though the specific reason has not been disclosed.

    Product
    GEO-MED CATARACT PACK, REF 89-5790.08
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0619-2023·2022-12-21

    Medical Device Podiatry Kit Recalled by DeRoyal Industries

    DeRoyal Industries is voluntarily recalling 76 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states. The specific reason for this Class II recall is not detailed in the public notice.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0084-2023·2022-12-21

    Homeopathic Calendula Oil Recalled for Manufacturing Practice Violations

    Atlantic Management Resources voluntarily recalls Menastil homeopathic calendula oil due to cGMP deviations. The 26 bottles (Lot A-01) were distributed nationwide and to Australia.

    Product
    Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2023·2022-12-21

    FDA Class II Recall of DeRoyal CUSTOM NEURO PACK, Voluntary

    DeRoyal Industries Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.

    Product
    DeRoyal CUSTOM NEURO PACK, REF 89-8392.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0683-2023·2022-12-21

    Medical device recall issued for DeRoyal CRANI PACK across multiple states

    DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.

    Product
    DeRoyal CRANI PACK, REF 89-10242.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0653-2023·2022-12-21

    FDA Recalls Medical Device: DeRoyal EMERGENT Trauma Pack

    DeRoyal Industries initiated a voluntary recall of the DeRoyal EMERGENT TRAUMA PACK (6 kits). The recall affects units distributed across 23 U.S. states.

    Product
    DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0652-2023·2022-12-21

    FDA Class II: DeRoyal Trauma Pack Voluntary Recall

    DeRoyal Industries initiated a voluntary recall of EMERGENT TRAUMA PACK kits (18 units) distributed to hospitals and medical facilities across 23 US states. The specific reason for the recall was not disclosed in the FDA notification.

    Product
    DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0643-2023·2022-12-21

    Voluntary Recall of DeRoyal Biopsy Pack Medical Device Kits

    DeRoyal Industries initiated a voluntary recall of 560 biopsy pack kits (lot 56094211) distributed across multiple US states. The specific reason for the recall was not documented in the available source.

    Product
    DeRoyal BIOPSY PACK, REF 89-9270.04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0583-2023·2022-12-21

    Medical device breast tray recalled by DeRoyal Industries Inc

    DeRoyal Industries voluntarily recalled 162 breast tray kits (REF 89-7033.07). The specific reason for the recall was not publicly disclosed.

    Product
    DeRoyal BREAST TRAY, REF 89-7033.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0637-2023·2022-12-21

    DeRoyal Orthopedic Kit Recalled; Reason Not Specified in Notice

    DeRoyal MAJOR ORTHO PACK kits (Ref 89-9250.07) are being voluntarily recalled. The specific reason is not provided in the FDA notice. Affected lots were distributed across 23 U.S. states.

    Product
    DeRoyal MAJOR ORTHO PACK, REF 89-9250.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0585-2023·2022-12-21

    Medical Device Recall: DeRoyal GU Robotic Pack, 192 Kits

    DeRoyal Industries has recalled 192 kits of the DeRoyal GU Robotic Pack (Lot 57387066, expires 9/1/2026) distributed across 23 U.S. states. The FDA classified this as a Class II recall.

    Product
    DeRoyal GU ROBOTIC PACK, REF 89-7063.12
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0582-2023·2022-12-21

    FDA Class II Recall of DeRoyal Cannulated Hip Pack Medical Devices

    DeRoyal Industries has initiated a voluntary recall of 36 kits of DeRoyal Cannulated Hip Pack medical devices distributed across 23 US states. No injuries or illnesses have been reported.

    Product
    DeRoyal CANNULTED HIP PACK, REF 89-6977.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0642-2023·2022-12-21

    Medical device NEURO PACK subject to nationwide voluntary recall

    DeRoyal Industries has issued a voluntary recall of 45 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed by the manufacturer.

    Product
    DeRoyal NEURO PACK, REF 89-9253.09
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0659-2023·2022-12-21

    FDA Class II Recall: DeRoyal Lumbar/Cervical Pack devices

    DeRoyal Industries Inc is recalling 360 units of LUMBAR/CERVICAL PACK (Reference 89-9521.11) medical devices. The firm initiated this voluntary Class II recall. No illnesses or injuries have been reported.

    Product
    DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0587-2023·2022-12-21

    Medical device recall for DeRoyal TRANS CANAL PACK units

    DeRoyal Industries Inc is voluntarily recalling 156 kits of the TRANS CANAL PACK medical device distributed across 23 U.S. states.

    Product
    DeRoyal TRANS CANAL PACK, REF 89-7157.12
    Category
    Medical Device
    Distribution
    0 states