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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4401–4425 of 5038

  • SevereFDA (Devices)·Z-0361-2015·2014-12-10

    Customed Shoulder Packs Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 126 shoulder packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0265-2015·2014-12-10

    Customed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0242-2015·2014-12-10

    Customed Tracheotomy Care Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0295-2015·2014-12-10

    Customed Angiography Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0340-2015·2014-12-10

    Customed Basic Pack 1 (III) Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0257-2015·2014-12-10

    Customed Mayo Stand Covers Recalled for Compromised Sterility

    Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0397-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0342-2015·2014-12-10

    Customed Cystoscopy Pack III Recalled for Sterility Compromise

    Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0319-2015·2014-12-10

    Customed Ophthalmic Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0251-2015·2014-12-10

    Customed Wound Management Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0293-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 D&C Laparoscopy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0244-2015·2014-12-10

    Customed Urethral Catheter Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Urethral Catheter Trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0367-2015·2014-12-10

    Customed Recalls 51 TLIF Packs Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0238-2015·2014-12-10

    Customed Irrigation Tray Recall Due to Compromised Sterility

    Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0472-2015·2014-12-03

    Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results

    Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.

    Product
    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and perm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0220-2015·2014-11-26

    Biomet Spine Recalls Durango Anchored ALIF Plate Due to Set Screw Risk

    Biomet Spine is voluntarily recalling 120 Durango Anchored ALIF Plate units because the set screw component may become dislodged from the plate assembly.

    Product
    LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0223-2015·2014-11-26

    Nidek Excimer Laser System Recalled Due to Fuse Holder Contact Failure

    Nidek Inc is recalling 14 EC-5000 CXIII Excimer Laser Corneal Surgery Systems because a contact failure in fuse holders could cause serious adverse events for patients.

    Product
    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-0171-2015·2014-11-19

    Siemens MicroScan Rapid Urine Combo Panel Recalled for False Positive Results

    Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.

    Product
    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultativel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0186-2015·2014-11-19

    GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners

    GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.

    Product
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare profession
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0182-2015·2014-11-19

    Philips Allura Xper FD20C Recalled for Faulty Motion Controller

    Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.

    Product
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and m
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0181-2015·2014-11-19

    Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault

    Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.

    Product
    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0188-2015·2014-11-19

    GE Optima NM/CT 640 Recalled for Loose Camera Fasteners

    GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera to fall onto a patient during a scan.

    Product
    Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0184-2015·2014-11-19

    GE Healthcare Infinia Nuclear Medicine Systems Recalled for Loose Fasteners

    GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0202-2015·2014-11-19

    Medacta Recalls GMK Intramedullary Extension Rods Due to Breakage Reports

    Medacta is recalling GMK Intramedullary Extension Rods 100 mm after three reported cases of breakage during total knee replacement surgeries.

    Product
    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0210-2015·2014-11-19

    Fisher and Paykel Infant Warmer Recall Due to Heater Head Breakage

    Fisher and Paykel Healthcare is recalling IW900-Series Infant Warmers and spare parts because a broken nut may allow the heater head to swing and injure infants.

    Product
    Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric
    Category
    Medical Device
    Distribution
    Distributed nationwide