The Recall Desk

Hazard

Design Defect recalls

108 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
108
Critical
1
Severe
11
Most recent
2026-08-12

Of the 108 design defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all design defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–75 of 108

  • HighFDA (Devices)·Z-0120-2020·2019-10-16

    Centurion Circlamp Recalled for Angle Mismatch Defect

    Centurion Medical Products is recalling 1,530 Circlamps due to a design mismatch that may cause the device to remove foreskin without a scalpel.

    Product
    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0707-2019·2019-01-16

    Siemens Biograph Horizon PET/CT System Recalled for Design Defects

    Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.

    Product
    Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2019·2018-10-31

    DePuy Mitek Screw and Washer Depth Gauge Recalled for Design Offset

    DePuy Mitek is recalling 401 Mitek Screw and Washer Depth Gauges because a design offset causes readings to be approximately 3.2mm shorter than the actual bone hole length.

    Product
    Mitek Screw and Washer Depth Gauge, Product Code 219024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2018·2018-04-11

    Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes

    Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.

    Product
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1260-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0349-2018·2018-01-24

    Zimmer Biomet Recalls Persona Partial Knee Finishing Guides

    Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.

    Product
    Persona Partial Knee System, Size 8, Finishing Guide
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0145-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2320-2016·2016-08-10

    Implant Direct Recalls RePlant Angled Abutments Due to Design Defect

    Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.

    Product
    RePlant¿ Angled Abutment Part Number 6050-52-60
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2200-2016·2016-07-20

    Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance

    Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.

    Product
    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is dispos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2015·2015-04-29

    Hospira PCA 3 Infusion Pump Recalled for Door Design Flaw

    Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0874-2015·2014-12-31

    Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency

    Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.

    Product
    Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2136-2014·2014-08-13

    X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery

    X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.

    Product
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2067-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for 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 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2077-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2080-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2079-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

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

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2074-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

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

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2061-2013·2013-09-04

    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 in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state