The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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35226–35250 of 40449

  • ModerateFDA (Devices)·Z-2247-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Trauma Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.

    Product
    6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2284-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling specific Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2264-2014·2014-08-27

    Hyperion Medical Recalls HyperBlue 1530 Laser Brochures for Misleading Claims

    Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.

    Product
    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2204-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2230-2014·2014-08-20

    Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.

    Product
    23.5 Deg Rasp Handle Assy- LEFT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2225-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2177-2014·2014-08-20

    Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts

    Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.

    Product
    Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2135-2014·2014-08-20

    Enhancement Medical Recalls Injectable Gel Due to Production Process Change

    Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.

    Product
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2203-2014·2014-08-20

    Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.

    Product
    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2155-2014·2014-08-20

    Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.

    Product
    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2209-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk

    Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2202-2014·2014-08-20

    Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2199-2014·2014-08-20

    Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2206-2014·2014-08-20

    Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.

    Product
    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2227-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2014·2014-08-20

    Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2226-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recall for Malfunction Risk

    Medical Positioning Inc is recalling 20 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position too rapidly.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2014·2014-08-20

    Biomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking

    Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.

    Product
    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2197-2014·2014-08-20

    Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2201-2014·2014-08-20

    Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2228-2014·2014-08-20

    Zimmer VER2 Handle Recalled Due to Assembly Failure During Use

    Zimmer, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 HANDLE, PIN REWORK, LT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide