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.

301–325 of 21708

  • ModerateFDA (Drugs)·D-0760-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.100 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2915-2026·2026-08-19

    GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling

    W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2935-2026·2026-08-19

    Straumann BLT Dental Implant Recall Due to Incorrect Length Labeling

    Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.

    Product
    Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2927-2026·2026-08-19

    Remel Neisseria meningitidis Gp C In Vitro Diagnostics Recall

    Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.

    Product
    Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0763-2026·2026-08-19

    Sildenafil Citrate Recall Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP 1.00KG bags due to CGMP deviations noted during an FDA inspection.

    Product
    SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2930-2026·2026-08-19

    Terumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging

    Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.

    Product
    GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0768-2026·2026-08-19

    Heritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles

    Heritage Pharmaceuticals is recalling Clindamycin Palmitate Hydrochloride oral solution due to the presence of particles and white flakes in reconstituted bottles.

    Product
    CLINDAMYCIN PALMITATE HYDROCHLORIDE — CLINDAMYCIN PALMITATE HYDROCHLORIDE (CLINDAMYCIN PALMITATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2913-2026·2026-08-19

    Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies

    Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.

    Product
    navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2026·2026-08-19

    Sildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection

    Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.

    Product
    SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2942-2026·2026-08-19

    Procedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.

    The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.

    Product
    Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2929-2026·2026-08-19

    Straumann Recalls GM Helix Dental Implants Due to Labeling Mismatch

    Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.

    Product
    GM Helix Implant, Endosseous Dental Implant Article No. 109.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2914-2026·2026-08-19

    GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling

    W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2917-2026·2026-08-19

    Galt Medical Recalls Boston Scientific Transcarotid Access Kits

    Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.

    Product
    Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2916-2026·2026-08-19

    Spacelabs Xhibit Central Station Recalled for DisplayPort Audio/Video Failures

    Spacelabs Healthcare is recalling 6,074 Xhibit Central Station units because an off-the-shelf DisplayPort audio/video splitter component may fail.

    Product
    Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2908-2026·2026-08-12

    COAPTIUM CONNECT medical device shelf life recalibration recall

    TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2026·2026-08-12

    Happiest Baby Recalls Pre-Loved SNOO Smart Sleeper Bassinets

    Happiest Baby, Inc is recalling 4 refurbished SNOO Smart Sleeper bassinets (Model S1000) that failed to meet quality standards before distribution. The recall is being reported retroactively.

    Product
    Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2026·2026-08-12

    Blom-Singer Voice Prosthesis Recalled Due to Incorrect Labeling

    Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.

    Product
    Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0733-2026·2026-08-12

    Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules

    Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.

    Product
    DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2895-2026·2026-08-12

    Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues

    Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1236-2026·2026-08-12

    Campo Rico Foods Recalls Frozen Shrimp Due to Nitrofurans

    Campo Rico Foods LLC is recalling 11 cases of Kanni Delight frozen shrimp because nitrofurans were detected in the product.

    Product
    Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF, Raw Peeled & Deveined Tail Off, Gross Weight: 5 lb., packaged in polyethylene bags, packed 6 bags per case, Product of India, Farm Raised, for food service only
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2871-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage

    Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2896-2026·2026-08-12

    5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues

    Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Control, Model Number 5D-44905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1193-2026·2026-08-12

    Flexible food pouches may release thin plastic strips into food

    Cheer Pack is recalling certain flexible food pouches because they may release thin plastic strips into food products.

    Product
    Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Organics Banana & Strawberry, 4 oz food puree, UPC 815367010780.
    Category
    Consumer Product
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2881-2026·2026-08-12

    Siemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2

    Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.

    Product
    Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
    Category
    Medical Device
    Distribution
    Distributed nationwide