Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
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.
DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
DeRoyal Industries is recalling 264 units of the ORTHO SPINE BACK PACK orthopedic device across 23 U.S. states as a voluntary, Class II recall. The specific reason for the recall is not provided in the available notice.
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.
DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the notice.
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.
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.
DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.
DeRoyal Industries Inc voluntarily recalled the DeRoyal TOTAL SHOULDER PACK (Lot 56658012, exp. 1/1/2024), affecting 30 kits distributed across 23 US states. The specific reason for recall is not disclosed in available FDA documentation.
DeRoyal Industries Inc has voluntarily recalled shoulder arthroscopy surgical packs distributed across 22 US states. The specific reason for recall was not disclosed in the FDA notification.
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.
The FDA has recalled Neuroquell Calendula Oil, a homeopathic drug, due to manufacturing practice violations. The voluntary recall affected 51 bottles distributed nationwide and in Australia.
DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
DeRoyal Industries has voluntarily recalled 304 kits of the BASIC NEURO PACK (REF 89-7523.16) across 23 states. The recall is ongoing.
Camber Pharmaceuticals is recalling specific lots of Lacosamide oral solution due to out-of-specification p-Hydroxybenzoic Acid content. The recall affects multiple lot numbers distributed nationwide.
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.
DeRoyal Industries recalled 64 DeRoyal Retinal Pack kits (Lot 57000221, Lot 57413324) distributed across 23 U.S. states. The specific reason for the recall was not disclosed.
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.
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.
DeRoyal Industries is recalling GEO-MED KNEE ARTHROSCOPY PACK units containing 3M Health Care Steri Drapes due to a supplier recall. No reported illnesses or injuries.
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.
DeRoyal Industries has issued a voluntary recall of 150 kits of the DeRoyal PAIN TRAY (Model 89-10464.03, Lot 57752107, expires 12/1/2026). The specific reason for the recall was not disclosed in the FDA notice.
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.
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.
The FDA is recalling 403 kits of DeRoyal lapinectomy packs distributed across 23 US states. The specific reason for the recall is not provided in the source documentation.
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.