The Recall Desk

State

Puerto Rico product recalls

72,933 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.

What the numbers show

Total
3,090
Critical
366
Severe
625
Most recent
2026-09-02

Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,933 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2776–2800 of 76023

  • HighFDA (Devices)·Z-1514-2026·2026-03-18

    Link Endo-Model SL connection component recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/07 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2026·2026-03-18

    GEM Premier 5000 PAK part 00055415004 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055415004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055415004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V165000·2026-03-18

    Ford and Lincoln image module resets can disable rearview camera

    Ford is recalling certain 2022-2025 Lincoln Navigator, Nautilus, Aviator and Explorer vehicles because the Image Processing Module A may reset unexpectedly, losing the rearview camera image and driver assistance features.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, EXPLORER, NAUTILUS, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2026·2026-03-18

    GEM Premier 5000 parts 00055445010 and 00055445011 may eject cartridges

    Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Part No. 00055445010 & 00055445011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407510 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407510.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407511 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407511.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2026·2026-03-18

    Link Endo-Model plateau 15-2835/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2835/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2835/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2026·2026-03-18

    GEM Premier 5000 part 00055415011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2026·2026-03-18

    Medline Medcrest surgical gowns may delaminate prematurely after recommended laundering

    Medline is recalling Medcrest surgical gowns because the fabric may delaminate prematurely when the included laundering instructions are followed.

    Product
    Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2026·2026-03-18

    Link Endo-Model plateau 15-0027/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407508 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2026·2026-03-18

    Link Endo-Model plateau 15-8030/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8030/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8030/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2026·2026-03-18

    GEM Premier 5000 part 00055445004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055445004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    GEM Premier 5000 part 00055430004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2026·2026-03-18

    GEM Premier 5000 part 00055430011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000 part 00055415005 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2026·2026-03-18

    GEM Premier 5000 part 00055430008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2026·2026-03-18

    IBA proton therapy system may not interrupt beam when gating fails

    Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.

    Product
    IBA Proton Therapy System - PROTEUS 235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2026·2026-03-18

    Raz shower commode chair seat may be reinstalled without engaging brackets

    Raz Design is recalling several Mobile Shower Commode Chair models because a vendor modification means the seat may be reinstalled without properly engaging the outside rear seat brackets that hold it in place.

    Product
    Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2026·2026-03-18

    Beckman Coulter AU5800 analyzer may stop analyzing after database errors

    Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2026·2026-03-18

    Link Endo-Model SL component 16-2840/05 recalled over bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2026·2026-03-18

    Artelon FlexBand Twist anchors failed bacterial endotoxin testing

    International Life Sciences is recalling the Artelon FlexBand Twist .12, ref TW012, because the augmentation devices failed bacterial endotoxin testing.

    Product
    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2026·2026-03-18

    Link Endo-Model plateau 15-8521/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2026·2026-03-18

    GEM Premier 5000 cartridges may eject repeatedly during analyzer warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Model No. 00055430010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2026·2026-03-18

    Clearest Strep-A cassette test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.

    Product
    Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide