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.

2076–2100 of 3531

  • ModerateNHTSA·21V831000·2022-10-10

    2022 BMW X4 Rear License Plate Lamp Illumination Defect

    BMW is recalling certain 2022 X4 vehicles because the rear license plate may not be properly illuminated, violating federal safety standards and potentially creating visibility issues for other drivers.

    Product
    BMW — 2022 BMW X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23003·2022-10-06

    Swift Industries Recalls 9-Inch Rubber Straps for Bicycle Bags

    Swift Industries is recalling 9-inch rubber straps used to fasten bicycle bags because the straps can break, causing the bag to fall and creating a crash hazard to riders. No injuries have been reported.

    Product
    9-inch Swift Straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2022·2022-10-05

    Leica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination

    Leica Microsystems is recalling 32 surgical operating microscopes due to a photodiode component defect that produces inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0004-2023·2022-10-05

    Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1794-2022·2022-10-05

    3M and Comply Sterilization Indicators Recalled for Temperature Excursions

    Sterilization indicator products from Mckesson Medical-Surgical distributed nationwide may have been exposed to higher temperatures between June and August 2021. The temperature excursions may have impacted product effectiveness in verifying sterilization processes.

    Product
    a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2022·2022-10-05

    Petrolatum Jelly Recalled Due to Temperature Exposure Prior to Delivery

    Petrolatum jelly products are being recalled because facility temperature excursions from June through August 2021 may have reduced product effectiveness. The FDA states this specific storage deviation is not likely to cause adverse health consequences.

    Product
    a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2022·2022-10-05

    Dynarex Unna Boot Dressing products recalled due to temperature storage excursion

    Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.

    Product
    a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1808-2022·2022-10-05

    HyVee Oven Baked Beans recalled for excessive potassium sorbate

    Hy-Vee, Inc. is recalling HyVee Oven Baked Beans (16 oz containers, lot #22175) because they contain an excessive amount of potassium sorbate. Consumers should not consume the affected product.

    Product
    HyVee Oven Baked Beans in 16 OZ plastic containers (UPC 0075450500640, 12 retail units per case)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1778-2022·2022-10-05

    Incompatible tibial bearing supplied for knee prosthesis installation

    An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.

    Product
    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1549-2022·2022-10-05

    Xolegel Ketoconazole Gel Recalled Due to Failed Viscosity Specification

    ALMIRALL, LLC is recalling 5,315 tubes of Xolegel ketoconazole 2% gel because tests found the product failed viscosity specifications, with out-of-specification results showing values slightly higher than acceptable.

    Product
    Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1809-2022·2022-10-05

    Dynarex Wet Wipes Recalled Due to Facility Temperature Exposure

    McKesson Medical-Surgical Inc. is recalling three Dynarex wet wipe products that may have been exposed to higher temperatures at the facility before delivery, potentially reducing their effectiveness. All lots received between June and September 2021 are affected.

    Product
    a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 24PK/CS) Catalog # 1322. c. DYNAREX dynacare WIPE, WET FLUSHABLE JR 5X8" (42/BX 12BX/CS) Catalog # 1324
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2022·2022-10-05

    Sterilization Chemical Indicator Strips Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.

    Product
    a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2023·2022-10-05

    Prescription Drug Esomeprazole Out of Specification for Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2022·2022-10-05

    McKesson Wound Dressing Products Recalled for Temperature Exposure

    McKesson wound dressing products distributed nationwide are being recalled due to exposure to elevated temperatures during storage that may have reduced their effectiveness. No adverse health consequences have been reported.

    Product
    a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2022·2022-10-05

    STERIS Sterilization Indicators Recalled Due to Temperature Excursions

    Six sterilization monitoring devices from STERIS Corporation were recalled due to temperature excursions during storage and delivery that may have compromised their effectiveness. Affected products were distributed nationwide between June and September 2021.

    Product
    a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2022·2022-10-05

    McKesson LiquiBand Exceed Skin Adhesive Storage Temperature Exposure Recall

    McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.

    Product
    a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1789-2022·2022-10-05

    Collagen Powder Recalled Due to Temperature Exposure During Shipment

    DermaCol 100 Collagen Powder was exposed to higher temperatures during storage from June to August 2021. The product's effectiveness may have been impacted, though the FDA determined no adverse health consequences are likely.

    Product
    DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1817-2022·2022-10-05

    Starling Monitor Devices Recalled for Incorrect Device Identification Labeling

    Baxter Healthcare is recalling Starling Monitor devices and accessories due to incorrect Unique Device Identification (UDI) information on labels and non-compliant barcodes. Approximately 9,671 units distributed nationwide are affected.

    Product
    Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2022·2022-10-05

    SporView Sterilization Biological Indicator Kit Recalled for Temperature Exposure

    McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.

    Product
    a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2022·2022-10-05

    Sterilization Roll Recalled Due to Temperature Exposure During Manufacturing

    SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.

    Product
    SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2022·2022-10-05

    Medical Monofilament Testing Devices Recalled for Temperature Excursion

    Mckesson Medical-Surgical is recalling monofilament sensory testing devices (13 units) due to temperature excursions during June-August 2021. Heat exposure may have compromised device effectiveness.

    Product
    Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2022·2022-10-05

    StayFIX Percutaneous Catheter Fixation Device Recalled Due to Storage Temperature Exposure

    MERIT MEDICAL SYSTEMS StayFIX catheter fixation devices recalled due to facility temperature excursions during storage before delivery. Approximately 109 units received between June-September 2021; manufacturer states no adverse health consequences are likely.

    Product
    MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2022·2022-10-05

    McKesson Calcium Alginate Wound Dressings Recalled for Temperature Exposure During Storage

    McKesson Medical-Surgical is recalling multiple calcium alginate wound dressings due to facility temperature excursions that may have impacted product effectiveness. The FDA states the affected products are not likely to cause adverse health consequences.

    Product
    a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2022·2022-10-05

    McKesson Absorbent Dressings Recalled Due to Temperature Storage Excursions

    McKesson absorbent dressings manufactured by Derma Sciences are being recalled due to temperature excursions during storage from June to August 2021. The FDA states the affected dressings are not likely to cause adverse health consequences.

    Product
    Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2022·2022-10-05

    Surgical Smoke Evacuation Prefilters Recalled Due to Temperature Exposure

    Cooper Surgical PREFILTER, SMOKE EVAC prefilters are recalled because they were exposed to higher temperatures during storage from June through August 2021. This exposure may have reduced the product's effectiveness.

    Product
    Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
    Category
    Medical Device
    Distribution
    Distributed nationwide