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.

3926–3950 of 21589

ModerateFDA (Drugs)·D-0082-2023·2022-12-21
FDA recalls Neuroquell Calendula Oil homeopathic drug for manufacturing deviations
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.
Product
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) 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-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-0584-2023·2022-12-21
DeRoyal Laparoscopic Robotic Tray Class II Medical Device Recall
DeRoyal Industries initiated a voluntary recall of 30 kits of a laparoscopic robotic surgical tray (Model 89-7063.11). The reason for the recall is not specified in available FDA records.
Product
DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
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-0716-2023·2022-12-21
Siemens Allergen Test Kit Recall: False Positive Mold Results
Siemens is recalling IMMULITE 2000 allergen test kits that may produce false positive results for mold allergies in both quality control and patient samples.
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the
Category
Medical Device
Distribution
Distributed nationwide
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
23 states
ModerateFDA (Drugs)·D-0094-2023·2022-12-21
Lacosamide oral solution recalled for failed excipient specifications
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.
Product
LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
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-0640-2023·2022-12-21
DeRoyal Foot Pack Medical Device Recalled in Multiple States
DeRoyal Industries Inc voluntarily recalls 105 kits of DeRoyal Foot Pack (Lot 57899862, exp 3/1/2025) distributed across 23 U.S. states. Affected customers should contact the firm for recall instructions.
Product
DeRoyal FOOT PACK, REF 89-9252.08
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0688-2023·2022-12-21
FDA Recalls DeRoyal PAIN TRAY Medical Device, Model 89-10464.03
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.
Product
DeRoyal PAIN TRAY, REF 89-10464.03
Category
Medical Device
Distribution
23 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
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-0707-2023·2022-12-21
Medical device recall: DeRoyal TRACECART posterior lumbar fusion kits
DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.
Product
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
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-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 (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-0648-2023·2022-12-21
DeRoyal Myelogram Packs Recalled for Inclusion of Defective 3M Drapes
DeRoyal Industries is recalling 480 myelogram procedure packs because they contain 3M Steri Drapes that have been recalled. These packs were distributed to medical facilities in 23 states.
Product
DeRoyal MYELOGRAM PACK, REF 89-9304.06
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-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-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-0675-2023·2022-12-21
Medical device neuro pack recalled voluntarily by DeRoyal Industries
DeRoyal Industries voluntarily recalled 159 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed in the FDA filing.
Product
DeRoyal NEURO PACK, REF 89-10171.06
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-0564-2023·2022-12-21
DeRoyal EYE TRAY Procedure Packs Recalled for Defective 3M Steri Drapes
DeRoyal Industries is recalling 48 kits of EYE TRAY procedure packs that contain 3M Health Care Steri Drapes which have been recalled.
Product
DeRoyal EYE TRAY, REF 89-4957.08
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0588-2023·2022-12-21
FDA Recalls DeRoyal Lapinectomy Surgical Pack Kits
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.
Product
DeRoyal LAPINECTOMY PACK, REF 89-7198.10
Category
Medical Device
Distribution
23 states