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.

Filters

Agency

Category

Minimum severity

Clear filters

3401–3425 of 5111

  • SevereFDA (Devices)·Z-1722-2018·2018-05-16

    Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation

    Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1724-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.

    Product
    BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1708-2018·2018-05-16

    Datascope Recalls Adult ECC Pack Due to Seal Separation Risk

    Datascope Corporation is recalling three units of the Adult ECC Pack BEQ-TOP 22300 because seal separation may allow air into the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1484-2018·2018-05-16

    Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk

    Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1483-2018·2018-05-16

    Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted ga
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1482-2018·2018-05-16

    Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally moun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1711-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.

    Product
    BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1739-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.

    Product
    Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1723-2018·2018-05-16

    Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation

    Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1720-2018·2018-05-16

    Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect

    Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.

    Product
    BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1623-2018·2018-05-16

    Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk

    Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.

    Product
    Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1718-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1666-2018·2018-05-16

    Baxter Infusion Pump Recalled for Improper Testing Documentation

    Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical dru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1706-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1713-2018·2018-05-16

    Datascope Recalls Better Bladder Device in Custom Tubing Kits

    Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may cause balloon collapse and reduced blood flow.

    Product
    BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1725-2018·2018-05-16

    Datascope recalls NICU ECC Pack custom tubing kits due to seal defect

    Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.

    Product
    NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1719-2018·2018-05-16

    Datascope recalls custom tubing kits with potential Better Bladder seal defect

    Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1716-2018·2018-05-16

    Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation

    Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.

    Product
    BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1699-2018·2018-05-16

    Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0801-2018·2018-05-16

    Coast Quality Pharmacy Recalls MAA Kits Due to Sterility Concerns

    Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.

    Product
    Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1709-2018·2018-05-16

    Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.

    Product
    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1715-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1721-2018·2018-05-16

    Datascope Custom Tubing Kit Recall Due to Seal Separation

    Datascope is recalling 9 custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
    Category
    Medical Device
    Distribution
    13 states