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.

3901–3925 of 21589

  • 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
    23 states
  • ModerateFDA (Devices)·Z-0668-2023·2022-12-21

    DeRoyal Facial Pack Medical Device Under Voluntary FDA Recall

    DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.

    Product
    DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0674-2023·2022-12-21

    FDA recalls DeRoyal NEURO PACK medical device kits across 23 states

    DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.

    Product
    DeRoyal NEURO PACK, REF 89-10171.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0628-2023·2022-12-21

    FDA Class II Medical Device Recall: DeRoyal Extremity Pack Kits

    DeRoyal extremity pack kits are subject to a voluntary FDA Class II recall. Three production lots distributed across 23 states are affected.

    Product
    DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0704-2023·2022-12-21

    Medical Device Recall: DeRoyal Surgical Knee Pack Components

    DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.

    Product
    DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0654-2023·2022-12-21

    DeRoyal EMERGENT TRAUMA PACK recall affects 18 kits across 23 states

    DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.

    Product
    DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Drugs)·D-0081-2023·2022-12-21

    Drug Neuroquell Plus Calendula Oil Recalled for Manufacturing Deviations

    Neuroquell Plus, a homeopathic calendula oil drug, has been voluntarily recalled due to current good manufacturing practice (cGMP) deviations. The recall affects 461 bottles distributed nationwide and in Australia.

    Product
    Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    23 states
  • ModerateFDA (Devices)·Z-0678-2023·2022-12-21

    DeRoyal laminectomy surgical instrument kits subject to Class II recall

    DeRoyal Industries is recalling LAMINECTOMY PACK surgical kits (Lot 56388471) distributed in multiple US states. Healthcare facilities with affected kits should verify their inventory and contact the manufacturer for guidance.

    Product
    DeRoyal LAMINECTOMY PACK, REF 89-10209.02
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0685-2023·2022-12-21

    DeRoyal Hand Pack Medical Device Recall Class II

    DeRoyal Industries initiated a voluntary recall of 18 DeRoyal Hand Pack medical device kits (Lot 56615021) distributed across 23 U.S. states. The specific reason for the recall is not provided in the available source material.

    Product
    DeRoyal HAND PACK, REF 89-10314.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0636-2023·2022-12-21

    DeRoyal BASIC EYE PACK Medical Device Voluntary Recall

    DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.

    Product
    DeRoyal BASIC EYE PACK, REF 89-9233.08
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0623-2023·2022-12-21

    Medical device eye pack manufactured by DeRoyal Industries recalled

    DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.

    Product
    DeRoyal EYE PACK, REF 89-8756.03
    Category
    Medical Device
    Distribution
    23 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
    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-0681-2023·2022-12-21

    FDA Recalls DeRoyal Pacemaker ICD Pack, Lot 57898501

    DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.

    Product
    DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0478-2023·2022-12-21

    CarePoint 60 mL Syringes Recalled Due to Green Substance on Plunger

    Allison Medical recalls CarePoint 60 mL syringes due to green substance found on plungers. While the substance is nontoxic, its potential interaction with medications is unknown.

    Product
    CarePoint 60 mL Syringe Without Needle, REF: 04-7560
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0634-2023·2022-12-21

    DeRoyal Hip Pack Medical Device Recall - Reason Unspecified

    DeRoyal Industries Inc recalled 16 kits of DeRoyal TOTAL HIP PACK (Lot 56042728, expiring May 1, 2026) distributed across 23 U.S. states. The specific reason for the recall was not provided in available agency documentation.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9113.06
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0604-2023·2022-12-21

    GEO-MED Lower Extremity Procedure Packs Recalled Due to Defective 3M Steri Drapes

    DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United States.

    Product
    GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
    Category
    Medical Device
    Distribution
    23 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
    23 states