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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37676–37700 of 40449

  • ModerateFDA (Devices)·Z-2062-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2112-2013·2013-09-04

    Becton Dickinson PrepStain Tecan US-II Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2013·2013-09-04

    SpineNet Bone Marrow Aspiration Needle Kit Recalled for Lack of FDA Clearance

    SpineNet is recalling 100 units of Bone Marrow Aspiration Needle Kits because they were marketed for use with the SpineNet ACC device without FDA clearance or approval.

    Product
    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2082-2013·2013-09-04

    Fresenius 2008 MeDS Pump Recalled for Venofer Dosage Accuracy Issues

    Fresenius Medical Care is recalling 132 MeDS pumps used to administer Venofer during hemodialysis because the device may not meet dosage accuracy requirements.

    Product
    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2013·2013-09-04

    Life Technologies Recalls HSV-2 Primers Due to Amplification Failure

    Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.

    Product
    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2106-2013·2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Component Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2060-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2052-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2013·2013-09-04

    Stryker Recalls Asnis III Cannulated Screws Due to Incorrect Length

    Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.

    Product
    Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2013·2013-09-04

    Pipeline Embolization Device Recalled for Missing Contraindication Information

    Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.

    Product
    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2118-2013·2013-09-04

    Ventana BenchMark and Discovery Instruments Recalled for Heating Element Defect

    Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.

    Product
    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2013·2013-09-04

    3M ESPE Recalls Unitek Primary Stainless Steel Crowns for Defective Edges

    3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.

    Product
    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2013·2013-09-04

    Becton Dickinson PrepStain Tecan US-I Recall for Incorrect Rack Settings

    Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2047-2013·2013-09-04

    Siemens PSA Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.

    Product
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2013·2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2013·2013-09-04

    Synthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling

    Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.

    Product
    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2058-2013·2013-09-04

    Synthes Trauma Nail System Recalled for Potential Outer Pouch Compromise

    Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.

    Product
    Synthes Trauma Nail System. The devices are indication for bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2088-2013·2013-09-04

    Siemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error

    Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.

    Product
    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2103-2013·2013-09-04

    SpineNet Anterior Cervical Cage Recalled for Incorrect Instructions for Use

    SpineNet is recalling 400 anterior cervical cages because the instructions for use contained statements that should have been removed prior to marketing.

    Product
    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2013·2013-09-04

    Zimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error

    Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.

    Product
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2057-2013·2013-09-04

    Synthes VA-LCP Distal Radius Plate Labeling Recall

    Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.

    Product
    Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2013·2013-09-04

    Becton Dickinson PrepStain AG System Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain AG. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2013·2013-09-04

    Siemens Axiom Artis C-arm Systems Recalled for Incorrect Channel Nuts

    Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.

    Product
    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
    Category
    Medical Device
    Distribution
    6 states