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.

1926–1950 of 3531

  • 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-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-0625-2023·2022-12-21

    Voluntary recall of DeRoyal ACDF Pack surgical implant kits

    A voluntary recall of 45 DeRoyal ACDF Pack surgical implant kits affects multiple US states. The recall reason was not specified in the available notice.

    Product
    DeRoyal ACDF PACK, REF 89-8779.03
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0664-2023·2022-12-21

    FDA Issues Class II Recall of DeRoyal Biopsy Pack Kits

    DeRoyal Industries has voluntarily recalled 180 units of its Biopsy Pack (Lot 56842514, exp. 8/1/2026) following an FDA Class II classification. The product was distributed across 23 U.S. states.

    Product
    DeRoyal BIOPSY PACK, REF 89-9739.05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0595-2023·2022-12-21

    Medical Device Recall: DeRoyal Custom Neuro Pack Kits

    DeRoyal Industries is recalling 36 kits of the Custom Neuro Pack distributed across 23 US states. The specific reason for this voluntary Class II recall was not disclosed in the available documentation.

    Product
    DeRoyal CUSTOM NEURO PACK, REF 89-7353.17
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0669-2023·2022-12-21

    FDA Class II recall: DeRoyal posterior laminectomy microdisc pack

    DeRoyal Industries initiated a recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.

    Product
    DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0630-2023·2022-12-21

    Medical device recall: DeRoyal cardiac kit Class II

    DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.

    Product
    DeRoyal KIT HEART B PACK, REF 89-9042.08
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0632-2023·2022-12-21

    FDA Class II Recall: DeRoyal Laminectomy Spinal Fusion Surgical Packs

    DeRoyal Industries has voluntarily recalled 90 kits of laminectomy spinal fusion surgical packs. The recall affects units distributed across 23 U.S. states. The specific reason for recall was not disclosed in available materials.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
    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-0576-2023·2022-12-21

    GEO-MED Plastic Hand Pack Medical Device Recall (Class II)

    DeRoyal Industries Inc initiated a voluntary recall of 165 kits of GEO-MED Plastic Hand Pack RF distributed across 23 US states. The specific reason for the Class II recall was not provided in the FDA notice.

    Product
    GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0666-2023·2022-12-21

    Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack Kits

    DeRoyal Industries initiated a voluntary recall of 363 shoulder arthroscopy surgical packs. The specific reason for the recall was not disclosed in the notice.

    Product
    DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0618-2023·2022-12-21

    DeRoyal BASIC PACK surgical kit voluntary medical device recall

    DeRoyal Industries Inc is voluntarily recalling 130 kits of the DeRoyal BASIC PACK medical device across 23 U.S. states due to an FDA Class II recall.

    Product
    DeRoyal BASIC PACK, REF 89-8633.07
    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-0656-2023·2022-12-21

    FDA Recalls DeRoyal Shoulder Kit Medical Device across 23 states

    DeRoyal Industries recalled 28 SHOULDER KIT units due to an unspecified Class II device defect. The affected lot numbers were distributed across 23 U.S. states between November 2022 and April 2025.

    Product
    DeRoyal SHOULDER KIT, REF 89-9497.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0647-2023·2022-12-21

    FDA Class II Recall of DeRoyal Myelogram Pack Kits

    DeRoyal Industries voluntarily recalled 2,280 myelogram pack kits across 23 U.S. states. No specific reason for the recall was provided in the official notice.

    Product
    DeRoyal MYELOGRAM PACK, REF 89-9304.05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0644-2023·2022-12-21

    DeRoyal Biopsy Pack medical device recall: Class II voluntary

    DeRoyal Industries voluntarily recalled 1200 biopsy pack kits distributed across 23 U.S. states. The reason for the recall was not disclosed in available source material.

    Product
    DeRoyal BIOPSY PACK, REF 89-9270.05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0691-2023·2022-12-21

    DeRoyal Cardiac Linen Pack Recalled, 204 Kits Affected

    DeRoyal Industries initiated an ongoing voluntary Class II recall of 204 kits of the DeRoyal CARDIAC LINEN PACK distributed to 23 U.S. states.

    Product
    DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
    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-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-0706-2023·2022-12-21

    Medical device shoulder arthroscopy surgical cart voluntary recall issued

    DeRoyal has voluntarily recalled 117 TRACECART shoulder arthroscopy kits distributed across 23 U.S. states. No illnesses or injuries have been reported. The specific reason for the recall is not disclosed in available FDA documentation.

    Product
    DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0577-2023·2022-12-21

    GEO-MED PLASTIC HAND PACK RF Medical Device Recall

    DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.

    Product
    GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0602-2023·2022-12-21

    DeRoyal Endovenous Procedure Packs Recalled Due to Affected Steri Drapes

    DeRoyal is recalling 88 endovenous procedure packs containing 3M Health Care Steri Drapes that have been recalled. The packs were distributed across 23 US states; consumers should stop using them immediately.

    Product
    DeRoyal ENDOVENOUS PACK, REF 89-7762.05
    Category
    Medical Device
    Distribution
    0 states