The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11901–11925 of 22152

  • HighFDA (Devices)·Z-1419-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled Due to Nonconforming Oxygen Barrier Packaging

    Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.

    Product
    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2024·2024-04-10

    Torrent Suite Dx Software versions affected by cybersecurity vulnerability

    Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.

    Product
    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2024·2024-04-10

    ARCHITECT Anti-HCV Reagent Kit Recalled for False Positive Results

    Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.

    Product
    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2024·2024-04-10

    Sterile blood collection tubes recalled for weak seal defect

    MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.

    Product
    Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2024·2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2024·2024-04-10

    Mobile X-ray System Structural Cable Defect Affects Safety Function

    Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.

    Product
    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2024·2024-04-10

    Medline Pediatric Magill Catheter Recalled for Weak Seal Risk

    Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.

    Product
    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2024·2024-04-10

    Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2024·2024-04-10

    Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation

    FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.

    Product
    Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging

    Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.

    Product
    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1459-2024·2024-04-10

    Medline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance

    Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.

    Product
    Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2024·2024-04-10

    Dental Rolls Recalled for Potential Sterility Breach from Weak Seal

    Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.

    Product
    Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1113-2024·2024-04-10

    Powerade Beverage Recall Due to Potential Metal Contamination

    The Coca-Cola Company is recalling specific lots of Powerade Mountain Berry Blast distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in some bottles.

    Product
    Powerade Mountain Berry Blast - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1478-2024·2024-04-10

    Skull Anchor Key Defect Prevents CT Localizer Attachment

    Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.

    Product
    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2024·2024-04-10

    Covidien Trocar Recall Due to Potential Seal Disengagement with Mesh

    Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2024·2024-04-10

    Cardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect

    Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.

    Product
    Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2024·2024-04-10

    Sterile tape/pen pack recalled for potential sterility breach

    Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.

    Product
    MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2024·2024-04-10

    Medline Swabsticks PVP Product Recalled for Weak Seal Risk

    Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2024·2024-04-10

    Medline wire cut scissors may have weak seal compromising sterility

    Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.

    Product
    MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2024·2024-04-10

    Stryker Infinity Resection Adjustment Block Recall: Missing Locking Screw

    Stryker recalled specific lots of Infinity Resection Adjustment Blocks due to a missing internal screw that locks the medial/lateral adjustment mechanism. The defect affects 47 units used in ankle arthroplasty procedures.

    Product
    stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1398-2024·2024-04-10

    BD Phoenix diagnostic panel recalled for drug cross-contamination

    Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.

    Product
    BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2024·2024-04-10

    Centurion Curette kits recalled for weak seals potentially compromising sterility

    Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.

    Product
    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2024·2024-04-10

    Medline Alcohol Swabsticks Recalled for Weak Seal Compromising Sterility

    Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1112-2024·2024-04-10

    Powerade Zero Fruit Punch Variety Pack Recalled for Potential Foreign Metal Object

    The Coca-Cola Company is recalling 149 cases of Powerade Zero Fruit Punch 20oz bottles distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in the product.

    Product
    Powerade Zero Fruit Punch - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
    Category
    Food
    Distribution
    2 states