The Recall Desk

Archive

December 2022 recalls

608 recalls were announced in December 2022.

What the numbers show

Critical
4
Severe
99
High
339
Moderate
165
Low
1

Of the 608 recalls this month scored against our rubric, 1% are Critical, 16% are Severe.

301–400 of 608

  • ModerateFDA (Devices)·Z-0710-2023·2022-12-21

    Surgical Supply Recall: DeRoyal Cataract Pack Class II 440 Kits

    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.

    Product
    DeRoyal CATARACT PACK, REF 89-8650.10
    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-0694-2023·2022-12-21

    DeRoyal Lumbar Disc Pack Medical Device Recalled as FDA Class II

    DeRoyal Industries initiated a voluntary recall of 12 kits of Lumbar Disc Pack medical devices distributed across 23 US states. Specific hazard details from the FDA are not available in the source data.

    Product
    DeRoyal LUMBAR DISC PACK, REF 89-10605.02
    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-0665-2023·2022-12-21

    DeRoyal Biopsy Pack Kits Subject to Voluntary Recall

    DeRoyal Industries voluntarily recalled 360 kits of its BIOPSY PACK (Lot 57686568) distributed across 22 U.S. states. The specific reason for the recall is not specified in available FDA documentation.

    Product
    DeRoyal BIOPSY PACK, REF 89-9739.06
    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-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-0687-2023·2022-12-21

    Medical device manufacturer recalls pain trays in 23 US states

    DeRoyal Industries is voluntarily recalling 1,100 kits of pain tray devices distributed across 23 US states. The FDA classified this as a Class II recall.

    Product
    DeRoyal PAIN TRAY, REF 89-10464.02
    Category
    Medical Device
    Distribution
    23 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
    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-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-0693-2023·2022-12-21

    DeRoyal Lumbar Disc Pack Medical Device Class II Recall

    DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.

    Product
    DeRoyal LUMBAR DISC PACK, REF 89-10590.02
    Category
    Medical Device
    Distribution
    23 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
    23 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
    23 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
    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-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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0613-2023·2022-12-21

    FDA Issues Class II Recall for DeRoyal SPINE PACK Medical Device Kits

    DeRoyal Industries Inc recalled 243 SPINE PACK medical device kits distributed across 23 US states as a Class II FDA recall. The specific reason for the recall is not detailed in the available notice.

    Product
    DeRoyal SPINE PACK, REF 89-8361.08
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0713-2023·2022-12-21

    DeRoyal cataract pack (Model 89-9241.04) recalled by FDA

    DeRoyal Industries initiated a voluntary recall of 552 units of its CATARACT PACK due to an unspecified defect. The FDA classified this Class II recall on December 15, 2022.

    Product
    DeRoyal CATARACT PACK, REF 89-9241.04
    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-0682-2023·2022-12-21

    Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack

    A voluntary recall of 56 kits of DeRoyal Shoulder Arthroscopy Packs (Model 89-10240.03, Lot 56465579) was initiated by DeRoyal Industries. The FDA classified this Class II recall, which affected multiple U.S. states.

    Product
    DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0701-2023·2022-12-21

    Surgical Device Recall: DeRoyal Shoulder Arthroscopy Pack

    DeRoyal Industries initiated a voluntary recall of its Shoulder Arthroscopy Pack (32 kits, Lot 56865450) distributed to healthcare facilities in 23 U.S. states. The specific reason for recall is not disclosed in FDA documentation.

    Product
    DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0467-2023·2022-12-21

    NexGen Option Stemmed Tibial Knee Component Recalled for Higher Revision Rates

    Zimmer Biomet is recalling NexGen Option Stemmed Tibial knee components (2,092 units) due to clinically significant higher revision rates when used with specific femoral components. The voluntary recall prevents future implantation with these problematic combinations.

    Product
    NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0586-2023·2022-12-21

    DeRoyal Cataract Procedure Packs Recalled Due to Affected 3M Steri Drapes

    DeRoyal Industries is recalling 190 cataract procedure packs that contain 3M Health Care Steri Drapes which have been recalled. The affected packs were distributed across 22 US states.

    Product
    DeRoyal CATARACT PACK, REF 89-7135.10
    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-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
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2023·2022-12-21

    Dental Procedure Trays Recalled for Incomplete Outer Bag Seal

    STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0568-2023·2022-12-21

    DeRoyal Surgical Procedure Packs Recalled for Defective Sterile Drapes

    DeRoyal Industries is recalling 135 surgical procedure kits containing recalled 3M Health Care Steri Drapes. The affected kits were distributed to 23 U.S. states.

    Product
    GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0614-2023·2022-12-21

    DeRoyal SPINE PACK procedure kits recalled due to included 3M Steri Drapes

    DeRoyal Industries is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.

    Product
    DeRoyal SPINE PACK, REF 89-8361.09
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0589-2023·2022-12-21

    FDA Class II Recall: DeRoyal Lapinectomy Pack Surgical Kits

    DeRoyal Industries initiated a voluntary recall of 715 Lapinectomy Pack surgical kits (Ref 89-7198.11) distributed to 23 US states. The FDA Class II recall remains ongoing.

    Product
    DeRoyal LAPINECTOMY PACK, REF 89-7198.11
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • 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-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
    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-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
    23 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
    23 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
    23 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-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-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
    23 states
  • ModerateFDA (Devices)·Z-0696-2023·2022-12-21

    FDA Medical Device Recall: DeRoyal GU Pack genitourinary kits

    DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA documentation.

    Product
    DeRoyal GU PACK, REF 89-10665.02
    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-0575-2023·2022-12-21

    DeRoyal shoulder procedure packs recalled for defective 3M Steri Drapes

    DeRoyal OPEN SHOULDER PROCEDURE PACK RF kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall. A total of 42 kits are affected.

    Product
    DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0606-2023·2022-12-21

    FDA Class II recall issued for DeRoyal BASIC EYE PACK medical device

    DeRoyal Industries Inc recalled 45 kits of its BASIC EYE PACK medical device distributed to healthcare facilities across the United States. The FDA classified this as a voluntary Class II recall.

    Product
    DeRoyal BASIC EYE PACK, REF 89-8337.08
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0697-2023·2022-12-21

    DeRoyal GU PACK Medical Device Voluntary Recall

    DeRoyal Industries Inc voluntarily recalled 57 kits of the DeRoyal GU PACK medical device. The specific reason for the recall was not provided in the available source documentation.

    Product
    DeRoyal GU PACK, REF 89-10665.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0714-2023·2022-12-21

    Cataract surgical pack Class II recall issued

    DeRoyal CATARACT PACK surgical kits are subject to a voluntary Class II recall affecting 108 kits across 23 U.S. states. The specific reason for the recall is not provided in available documentation.

    Product
    DeRoyal CATARACT PACK, REF 89-10040.01
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0083-2023·2022-12-21

    Drug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations

    ProSirona Homeopathic Calendula Oil (Lot B-02) is being recalled because the manufacturer failed to follow Current Good Manufacturing Practice standards. The voluntary recall affects products distributed nationwide and in Australia.

    Product
    ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    23 states
  • ModerateFDA (Devices)·Z-0698-2023·2022-12-21

    FDA Class II Recall: DeRoyal NEURO PACK medical device kits

    DeRoyal Industries recalled 270 NEURO PACK kits (REF 89-10682.02) distributed across 23 US states. The specific reason for the recall was not disclosed in the FDA notice.

    Product
    DeRoyal NEURO PACK, REF 89-10682.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0624-2023·2022-12-21

    Surgical Kit Recall: DeRoyal Shoulder Arthroscopy Pack Class II

    DeRoyal Industries initiated a Class II recall of 100 shoulder arthroscopy surgical kits distributed across 23 U.S. states. The specific defect has not been publicly disclosed in FDA records.

    Product
    DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04
    Category
    Medical Device
    Distribution
    23 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
    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-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
  • 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-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-0570-2023·2022-12-21

    GEO-MED Podiatry Pack Recalled Due to Previously Recalled Component

    DeRoyal Industries is recalling 184 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states because they contain 3M Health Care Steri Drapes that were previously recalled. The affected kits have specific lot numbers with expirations through February 2025.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0593-2023·2022-12-21

    Medical device recall: DeRoyal VIT RD PACK 86ST, FDA Class II

    DeRoyal Industries recalls 16 kits of DeRoyal VIT RD PACK 86ST medical devices distributed across 23 US states. This is a voluntary firm-initiated FDA Class II recall.

    Product
    DeRoyal VIT RD PACK 86ST, REF 89-7308.09
    Category
    Medical Device
    Distribution
    23 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
    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-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-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-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-0672-2023·2022-12-21

    FDA Medical Device Recall: DeRoyal Shoulder Pack (Class II)

    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.

    Product
    DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0661-2023·2022-12-21

    FDA Recalls 75 DeRoyal UNIVERSAL PACK Medical Device Kits

    DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available documentation.

    Product
    DeRoyal UNIVERSAL PACK, REF 89-9558.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0622-2023·2022-12-21

    FDA Class II Medical Device Recall: GEO-MED Biopsy Tray

    DeRoyal Industries Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.

    Product
    GEO-MED BIOPSY TRAY, REF 89-8753.01
    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-0705-2023·2022-12-21

    FDA Recalls DeRoyal Biopsy Packpack Medical Device across Multiple States

    DeRoyal Industries is recalling 120 units of Biopsy Packpack medical devices distributed across 23 states. The specific reason for the recall is not disclosed in the FDA notice.

    Product
    DeRoyal BIOPSY PACKPACK, REF 89-9756.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0608-2023·2022-12-21

    Medical device heart pack kit recalled by DeRoyal Industries

    DeRoyal Industries is recalling 240 DeRoyal HEART PACK medical device kits (REF 89-8351.11). The specific reason for the recall is not disclosed in the FDA notice.

    Product
    DeRoyal HEART PACK, REF 89-8351.11
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0657-2023·2022-12-21

    DeRoyal TOTAL HIP KIT medical devices recalled by manufacturer

    DeRoyal Industries is voluntarily recalling 51 units of the DeRoyal TOTAL HIP KIT (Lot 56187960 and 57031051) distributed to healthcare facilities across 23 US states.

    Product
    DeRoyal TOTAL HIP KIT, REF 89-9498.08
    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-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-0578-2023·2022-12-21

    Medical device recall: GEO-MED Total Knee Pack surgical kits

    DeRoyal Industries voluntarily recalled 49 kits of the GEO-MED TOTAL KNEE PACK A & B distributed across 23 U.S. states. The specific reason for the recall is not detailed in the FDA notice.

    Product
    GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0699-2023·2022-12-21

    Medical Device Class II Recall: DeRoyal LAMI/CRANI PACK surgical kits

    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.

    Product
    DeRoyal LAMI/CRANI PACK, REF 89-10787.01
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0679-2023·2022-12-21

    DeRoyal Lumbar Fusion Pack Subject to FDA Class II Recall

    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.

    Product
    DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
    Category
    Medical Device
    Distribution
    23 states
  • SevereNHTSA·22V943000·2022-12-20

    New Flyer Transit Buses Recalled for Steering Column Defect

    New Flyer is recalling 746 transit buses because a loose steering column connection may cause loss of steering, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XT40, XDE35, XN40, XT60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V942000·2022-12-19

    2023 BMW X5 driver seat backrest fastener defect recall

    BMW is recalling certain 2023 X5 models because one of four bolts connecting the driver's seat backrest to the frame may not have been correctly installed, potentially preventing proper occupant restraint during a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V939000·2022-12-16

    Peterbilt 320 and 520 Refuse Trucks Recalled for Suspension Defect

    PACCAR is recalling 2015-2023 Peterbilt 320 and 520 refuse trucks because suspension brackets may fail, causing axle instability and increasing crash risk.

    Product
    PETERBILT — PETERBILT 320, 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V934000·2022-12-16

    Lightning eMotors Recalls FE4 Vehicles for Battery Power Loss Risk

    Lightning eMotors is recalling 2021-2022 FE4-129 vehicles because the high-voltage battery may lose traction power or fail to start, increasing crash risk.

    Product
    LIGHTNING EMOTORS — LIGHTNING EMOTORS FE4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V936000·2022-12-16

    Mercedes-Benz Recalls GLE and GLS Models for Steering Screw Defect

    Mercedes-Benz is recalling 2021-2022 GLE and GLS vehicles because a steering coupling locking screw may loosen, potentially causing a loss of steering control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE63, GLS 450 4MATIC, AMG GLE53, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V937000·2022-12-16

    Mercedes-Benz Recalls 2022 AMG G63 Due to Rear Axle Defect

    Mercedes-Benz is recalling 278 2022 AMG G63 vehicles because the rear axle differential housing may crack or break, potentially causing loss of control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V941000·2022-12-16

    Hyundai Recalls 2021 Kona Electric Vehicles Due to EPCU Coolant Leak Risk

    Hyundai is recalling 2021 Kona Electric vehicles because a defective Electric Power Control Unit may leak coolant, potentially causing a loss of drive power and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI KONA ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V935000·2022-12-16

    Mercedes-Benz Recalls One 2022 S 500 for Dashboard Attachment Defect

    Mercedes-Benz is recalling one 2022 S 500 vehicle because the dashboard may be insufficiently attached, which can result in improper front passenger air bag deployment.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S 500 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V940000·2022-12-16

    Peterbilt 579 Hood Mirror Assemblies May Break and Fall

    PACCAR is recalling certain 2022–2023 Peterbilt 579 vehicles because the molded hood mirror assemblies may break at the pivot joint and fall into the roadway, creating a road hazard.

    Product
    PETERBILT — PETERBILT 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V938000·2022-12-16

    Mercedes-Benz Recalls 2019 AMG GT Models for Center Console Defect

    Mercedes-Benz is recalling 2019 AMG GT53 and GT63 vehicles because the center console may unlatch during a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT 63, AMG GT53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·044-2022·2022-12-15

    Mountain View Packaging Recalls Frozen Crispy Chicken Entrée for Undeclared Shrimp

    Mountain View Packaging is recalling frozen Crispy Chicken with Almonds entrée due to undeclared shrimp, a known allergen. No adverse reactions have been reported.

    Product
    Mountain View Packaging, LLC — Mountain View Packaging, LLC, Recalls Frozen Ready-To-Eat Crispy Chicken with Almonds Entrée Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·23716·2022-12-15

    Gyroor C3 E-Bikes Recalled for Fire and Burn Hazards

    Gyroor C3 e-bikes are recalled because the battery pack can ignite, creating fire and burn hazards. Gyroor has received reports of battery packs igniting and injuries requiring medical treatment, including burns and smoke inhalation.

    Product
    Gyroor C3 e-bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V930000·2022-12-15

    Chevrolet Bolt EV Pretensioner Exhaust Fire Risk Recall

    General Motors recalls 2017-2023 Chevrolet Bolt EV vehicles. After a crash with pretensioner deployment, pretensioner exhaust may ignite carpet near the B-pillar, creating a fire hazard.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2022.