The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–125 of 1441

  • ModerateFDA (Devices)·Z-2422-2025·2025-09-03

    Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement

    Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.

    Product
    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    FARAWAVE ablation catheters may have cracks in the distal electrode bands

    FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output

    Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2025·2025-07-30

    ACUVUE OASYS MAX multifocal daily lenses have bubbles and voids

    ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0499-2025·2025-07-09

    Bupivacaine HCL Sterile Injection Recalled for Sterility Assurance Concerns

    Tailstorm Health Inc. is recalling bupivacaine HCL sterile injection vials nationwide due to FDA inspection findings regarding concerns with the sterile manufacturing process.

    Product
    BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2025·2025-07-09

    My3D Personalized Solutions Humeral Cup lacks required inspections

    Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.

    Product
    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0473-2025·2025-07-02

    Metoclopramide Tablets Recalled for Presence of Foreign Tablets

    Teva Pharmaceuticals USA, Inc. is recalling Metoclopramide Tablets, USP 10 mg due to the presence of foreign tablets or capsules in the product. The affected lot is distributed nationwide.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2025·2025-06-25

    Prestige Coil System implantable devices recalled for manufacturing defect

    BALT USA is recalling Prestige Coil System implantable embolization devices because radiopaque markers on some units were not manufactured to specification and were not visible during angiography.

    Product
    Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2025·2025-06-25

    Surgical Mesh Product Recalled Due to Residual Adhesive Material

    Chamberlain Technologies is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The product was distributed to facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1983-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH WN Polymeric Surgical Mesh due to potential residual adhesive material on the mesh surface. The 60-unit recall affects medical facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1907-2025·2025-06-11

    Beckman Coulter Sample Probe Manufacturing Defect Recall

    Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2025·2025-06-04

    BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.

    Product
    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1808-2025·2025-05-28

    BD Cathena Safety IV Catheter manufacturing defect hole septum

    Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.

    Product
    BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0429-2025·2025-05-28

    Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations

    Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.

    Product
    RAPIDOL — RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0425-2025·2025-05-28

    KOFAL Original Pain Relieving Ointment Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.

    Product
    KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0438-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recall Due to Manufacturing Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1806-2025·2025-05-28

    Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect

    Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.

    Product
    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2025·2025-05-07

    Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations

    Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles distributed nationwide.

    Product
    Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0381-2025·2025-04-30

    Kingskin Salicylic Acid Wart Removal Recall Due to cGMP Deviations

    Pharmadel, LLC is recalling Kingskin salicylic acid wart-removal solution due to cGMP manufacturing deviations. The recall affects 20,048 bottles distributed in Delaware.

    Product
    KINGSKIN — KINGSKIN (SALICYLIC ACID)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0375-2025·2025-04-30

    Hemopropin Ointment Recalled Due to Manufacturing Process Deviations

    Apipharma is voluntarily recalling Hemopropin Ointment due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects specific lot numbers distributed in Arizona.

    Product
    Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0386-2025·2025-04-30

    Bimatoprost Bulk Powder Recalled by Medisca for CGMP Deviations

    Medisca Inc. is voluntarily recalling Bimatoprost bulk powder in three sizes due to manufacturing process deviations. The powder was distributed nationwide.

    Product
    Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2025·2025-04-23

    Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk

    Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.

    Product
    Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0363-2025·2025-04-23

    Testosterone Cypionate Injection Recalled for Insoluble Crystals

    Eugia US LLC is recalling Testosterone Cypionate Injection due to complaints that crystals do not redissolve into solution after warming and shaking. The defect may affect product safety and efficacy.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide