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 deaths or serious injuries are reported, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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13426–13450 of 13836

  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2021·2021-07-28

    Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure

    Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.

    Product
    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the s
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2107-2021·2021-07-28

    Suture Anchor Products Recalled Due to Improper Sterilization

    Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.

    Product
    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2021·2021-07-28

    Blood heater-cooler devices recalled for water contamination and infection risk

    Gentherm's Hemotherm CE blood cooler/heater devices may harbor dangerous organisms including nontuberculous mycobacteria in their water systems that could aerosolize during cardiac surgery, risking patient infection.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2021·2021-07-28

    Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport

    A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.

    Product
    The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects t
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2127-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear

    Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled due to premature wear risk

    Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL hip implant liners are being recalled due to risk of edge-loading and premature wear in certain surgical configurations. Approximately 89,050 units distributed nationwide may be affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2021·2021-07-28

    Cell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance

    Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.

    Product
    Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2118-2021·2021-07-28

    Hip implant polyethylene liners recalled due to premature wear risk

    Exactech Connexion GXL acetabular liners used in hip implants are recalled due to risk of edge-loading and premature wear in patients with specific implant configurations and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2021·2021-07-28

    Mindray battery cradle may prevent monitor from powering on

    Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

    Product
    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2085-2021·2021-07-28

    Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport

    Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.

    Product
    026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2019-2021·2021-07-21

    INTUA CRT-P Pacemakers Recalled Due to Battery Degradation Risk

    The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.

    Product
    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1974-2021·2021-07-21

    Philips Respironics ventilators recalled for degrading foam and chemical hazards

    Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.

    Product
    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2020-2021·2021-07-21

    Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall

    Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.

    Product
    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1958-2021·2021-07-21

    Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk

    Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.

    Product
    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2021·2021-07-21

    Philips Respironics E30 ventilator foam degradation poses inhalation hazard

    Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.

    Product
    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for indiv
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2015-2021·2021-07-21

    Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

    Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.

    Product
    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2017-2021·2021-07-21

    VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets

    Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.

    Product
    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1956-2021·2021-07-21

    Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk

    Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1973-2021·2021-07-21

    Philips Respironics ventilators recalled due to foam degradation and chemical release

    Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.

    Product
    DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individu
    Category
    Medical Device
    Distribution
    0 states