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.

5276–5300 of 21589

  • ModerateFDA (Devices)·Z-0039-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks

    ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.

    Product
    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2022·2021-10-13

    Dental implant scan abutment recalled for dimensional tolerance and marking defects

    Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.

    Product
    Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2022·2021-10-13

    ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

    ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

    Product
    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2022·2021-10-13

    OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect

    Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.

    Product
    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2022·2021-10-13

    Medical cooler-heater device recalled for inadequate maintenance and inspection guidance

    CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0043-2022·2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.

    Product
    ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2022·2021-10-13

    Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance

    CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2022·2021-10-13

    Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

    ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.

    Product
    Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·037-2021·2021-10-08

    Crider Foods Recalls Canned Beef With Gravy Due to Lead Contamination

    Crider Foods is recalling approximately 684,774 pounds of canned beef with gravy products due to possible unsafe levels of lead from a spice mix.

    Product
    Crider, Inc. — Crider Foods Recalls Canned Beef With Gravy Products Due to Possible Unsafe Levels of Lead From Outside Source
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2021·2021-10-06

    Neutrogena Ultra Sheer SPF 30 Body Mist Sunscreen Recall

    Johnson & Johnson Consumer, Inc. is recalling approximately 196,380 cans of Neutrogena Ultra Sheer body mist sunscreen SPF 30 nationwide due to cGMP deviations. This is a voluntary recall initiated by the manufacturer.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0833-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer is recalling Neutrogena Beach Defense water + sun protection sunscreen spray in two sizes (6.5 oz and 8.5 oz) nationwide due to current good manufacturing practice (cGMP) deviations.

    Product
    Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0867-2021·2021-10-06

    Quebracho Homeopathic Pills Fail Identification Testing

    Washington Homeopathic Products is recalling Quebracho homeopathic pills in multiple potencies because testing identified out-of-specification results during identification analysis.

    Product
    Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C Packaged as b) 4 Dram UPC 7 40640 44092 6; c) 2 oz UPC 7 40640 44100 8; 12C Packaged as d) 4 Dram; e) 2 oz; 30C Packaged as f) 2 dr UPC 7 40640 44090 2; g) 4 Dram, UPC 7 40640 44094 0; h) 1 o
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0839-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 100+ nationwide due to manufacturing deviations. Approximately 3.98 million cans are affected.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2021·2021-10-06

    Z-1050 Formula Hepatodetox Homeopathic Medicine Fails Identification Testing

    Washington Homeopathic Products, Inc. is recalling Z-1050 Formula Hepatodetox 1000ml bottles because out-of-specification test results were obtained during identification testing based on HPTLC analysis.

    Product
    Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2021·2021-10-06

    Aconitum Napellus Homeopathic Pills Fail Quality Test

    Washington Homeopathic Products is recalling Aconitum napellus Fear pills in multiple potencies nationwide due to failed identification testing by high-performance thin-layer chromatography (HPTLC).

    Product
    Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 7X, 12X, packaged in 2 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 12X, 20X, packaged in 2 oz containers, Aconitum
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2021·2021-10-06

    Aconitum Napellus Fear Pills Recalled for Failed Quality Testing

    Washington Homeopathic Products is recalling Aconitum Napellus Fear homeopathic pills in multiple potencies and package sizes (562 bottles, Lot #26198) distributed nationwide because test results showed out-of-specification identification results on HPTLC analysis.

    Product
    Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2021·2021-10-06

    Neutrogena Invisible Daily Defense Body Spray Sunscreen Recall

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Invisible Daily Defense body spray sunscreen (SPF 60+) due to cGMP deviations. The recall affects approximately 88,380 cans distributed nationwide.

    Product
    Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Product Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear 20% Alcohol homeopathic medicine (Lot #26198) distributed nationwide due to out-of-specification test results from HPTLC identification analysis.

    Product
    Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2021·2021-10-06

    Viola Odorata Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Viola Odorata homeopathic medicine (Lot #29057, expiration 8/17/2026) distributed nationwide because identification testing using HPTLC analysis returned out-of-specification results.

    Product
    Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0834-2021·2021-10-06

    Johnson & Johnson Neutrogena COOLDRY SPORT Sunscreen Spray Recalled

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena COOLDRY SPORT sunscreen spray (SPF 50) due to cGMP deviations. Approximately 867,816 cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0890-2021·2021-10-06

    Strophanthus hisp 30X Homeopathic Hives Pills Recalled for Testing Failures

    Washington Homeopathic Products is recalling Strophanthus hisp 30X Hives pills after testing identified out-of-specification results in identification tests. The recall affects approximately 91 bottles distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 47537 9; (c) 1 oz, UPC 7 40640 47541 6; (d) 2 oz, UPC 7 40640 47545 4; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0882-2021·2021-10-06

    Z-1020 Formula Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-1020 Formula due to out-of-specification test results on identification testing. The product was distributed nationwide.

    Product
    Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2021·2021-10-06

    Neutrogena Ultra Sheer Body Mist Sunscreen Recall for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 70 (5.0 oz aerosol cans) due to cGMP manufacturing deviations. The product was distributed nationwide.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0859-2021·2021-10-06

    Washington Homeopathic Products Occular Allergy Blend fails identification testing

    Washington Homeopathic Products is recalling Occular Allergy Blend 87% Alcohol (Lot # 30148, 500 mL bottles) distributed nationwide due to out-of-specification test results in identification testing.

    Product
    Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla 7X, WHP Homeopathic Medicine For Manufacturing Only, 500 ml. Manufcatured by Washington Homeopathic Products 260JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1023-2021·2021-10-06

    Crunchy Cones Chocolate recalled for undeclared sulfites

    Borinquen Cones of Puerto Rico is recalling Crunchy Cones Chocolate (12-count, 40oz boxes, Lot 24521) because the product label does not declare the presence of sulfites.

    Product
    Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)
    Category
    Food
    Distribution
    0 states