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 deaths or serious injuries are reported, 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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

4926–4950 of 5038

  • SevereFDA (Devices)·Z-0146-2013·2012-10-31

    DePuy Mitek Recalls 94 SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 94 SpiraLok 6.5mm anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0155-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 4,321 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk

    DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0145-2013·2012-10-31

    SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk

    DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.

    Product
    SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2013·2012-10-31

    Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports

    Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.

    Product
    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0143-2013·2012-10-31

    SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture

    DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.

    Product
    SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0149-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers all lot codes distributed worldwide.

    Product
    SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0153-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk

    DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.

    Product
    SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0019-2013·2012-10-17

    Accutron Recalls Flowmeter Packages for Incorrect Gas Function

    Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may function incorrectly when nitrous gas flows without oxygen.

    Product
    CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0027-2013·2012-10-17

    OrthoHelix 3.8mm Cannulated Hex Drivers Recalled for Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.

    Product
    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0028-2013·2012-10-17

    Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns

    Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.

    Product
    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0053-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0049-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions

    Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.

    Product
    Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0050-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall

    Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.

    Product
    Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0026-2013·2012-10-17

    OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.

    Product
    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0051-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0017-2013·2012-10-17

    Accutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function

    Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.

    Product
    Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2483-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0011-2013·2012-10-10

    Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk

    Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.

    Product
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2480-2012·2012-10-10

    Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2481-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2478-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.

    Product
    12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40
    Category
    Medical Device
    Distribution
    Distributed nationwide