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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5001–5025 of 5038

  • SevereFDA (Devices)·Z-2168-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2165-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Suture Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2139-2012·2012-08-15

    Baxter Recalls Automix High Speed Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.

    Product
    AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2091-2012·2012-08-08

    Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk

    Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.

    Product
    Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2092-2012·2012-08-08

    Zimmer Recalls Nextgen Knee Replacement Jaw Instruments Due to Fracture Risk

    Zimmer Inc. is recalling Nextgen Complete Knee Solution replacement jaws because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.

    Product
    Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2012·2012-08-08

    Sunrise Medical Recalls Padded Swing Away Arm Rests Due to Injury Reports

    Sunrise Medical is recalling 14,035 Padded Swing Away Arm Rests for specific wheelchair models because reports indicate injury when the armrest is used to support full body weight.

    Product
    Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2012·2012-08-01

    GE OEC 9800 C-arm Systems Recalled for Power Supply Defect

    GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.

    Product
    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pro
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2082-2012·2012-08-01

    Hill-Rom Recalls Affinity Four Birthing Beds Due to Fall Risk

    Hill-Rom is recalling 12,726 Affinity Four Birthing Beds because bed movement during labor may cause patient or caregiver falls.

    Product
    Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2077-2012·2012-08-01

    Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk

    The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.

    Product
    .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2014-2012·2012-07-25

    Etac Walker Recall Due to Wheel Detachment and Fall Risk

    Etac Supply Center Ab is recalling Ono, Avant, and Salsa walkers because wheels may fall off, posing a risk of serious injury or death.

    Product
    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1981-2012·2012-07-18

    Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

    Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.

    Product
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and ro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1980-2012·2012-07-18

    Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

    Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.

    Product
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1983-2012·2012-07-18

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.

    Product
    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1938-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1937-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 683 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage during use.

    Product
    Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1905-2012·2012-07-11

    Invacare Recalls TDX Power Wheelchairs Due to Fire and Injury Risk

    Invacare is recalling specific TDX power wheelchairs because a defect in the post fuse assembly could cause a short circuit, leading to fire and serious injury.

    Product
    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 530 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1914-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is recalling ULTIMA LX and LUSTER cemented polished femoral hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1940-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.

    Product
    Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2012·2012-07-11

    CareFusion Infant Y Connector Recall Due to Spontaneous Cracking

    CareFusion is recalling AirLife Infant Patient Y Connectors because the adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1923-2012·2012-07-11

    DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1883-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of some tips can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1884-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some cannula tips that can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1893-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could dislodge.

    Product
    CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during
    Category
    Medical Device
    Distribution
    Distributed nationwide