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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24751–24775 of 27686

  • HighFDA (Devices)·Z-2241-2014·2014-08-27

    FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining

    Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.

    Product
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2245-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.

    Product
    Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2259-2014·2014-08-27

    Medtronic Recalls Six Activa PC Implantable Neurostimulators

    Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

    Product
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2252-2014·2014-08-27

    Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues

    Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.

    Product
    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2293-2014·2014-08-27

    ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

    ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.

    Product
    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2014·2014-08-27

    Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk

    Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.

    Product
    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2290-2014·2014-08-27

    Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk

    Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.

    Product
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2298-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2014·2014-08-27

    Invivo Recalls Philips IP5 MRI Patient Monitoring Devices

    Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.

    Product
    Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures

    Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

    Product
    6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2301-2014·2014-08-27

    Zimmer Recalls Persona Knee System Trial Components Due to Breakage

    Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.

    Product
    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches

    Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.

    Product
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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