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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21126–21150 of 40339

  • HighFDA (Devices)·Z-1081-2019·2019-04-10

    Biomet Cement Plug Inserter Recalled for Sterilization Validation Issues

    Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.

    Product
    Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2019·2019-04-10

    Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error

    Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.

    Product
    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1077-2019·2019-04-10

    Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

    Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.

    Product
    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1075-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2019·2019-04-10

    Advanced Bionics Recalls Three Naída CI Q70 Sound Processors

    Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1079-2019·2019-04-10

    Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors

    Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.

    Product
    iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1085-2019·2019-04-10

    Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error

    Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1083-2019·2019-04-10

    Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

    Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1074-2019·2019-04-10

    Abbott Recalls CELL-DYN Emerald Analyzers Due to Quality Control Errors

    Abbott Laboratories is recalling 6,353 CELL-DYN Emerald analyzers worldwide because they may generate incorrect low quality control results for red blood cells and platelets.

    Product
    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1088-2019·2019-04-10

    Beaver Visitec Recalls Micro Knife 5.0mm Due to Misprinted Expiration Date

    Beaver Visitec is recalling 97 boxes of Micro Knife 5.0mm 30° instruments because the expiration date was misprinted as the lot number.

    Product
    Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1080-2019·2019-04-10

    McKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues

    Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.

    Product
    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-1042-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1072-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1070-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk

    ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0986-2019·2019-04-03

    Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect

    Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.

    Product
    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1044-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1053-2019·2019-04-03

    Philips UroDiagnost MRF Recall Due to Missing Locking Plate

    Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2019·2019-04-03

    Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate

    Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.

    Product
    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling 280 Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1058-2019·2019-04-03

    Sunset Compressor Nebulizer Recalled for Overheating and Mouthpiece Detachment Risk

    SANRAI INTERNATIONAL LLC is recalling 150 Sunset Compressor Nebulizer units in South Africa due to voltage incompatibility risks.

    Product
    Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1066-2019·2019-04-03

    Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath

    Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.

    Product
    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2019·2019-04-03

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns

    Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.

    Product
    Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2019·2019-04-03

    LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Risk

    LW Scientific is recalling ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard.

    Product
    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states