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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9276–9300 of 13731

HighFDA (Devices)·Z-1906-2023·2023-06-21
Prosthetic Socket Ratchet Locking Systems Recalled for Suspension Loss Risk
Mechanical locking devices for prosthetic sockets may develop accelerated wear that causes the attachment pin to disengage, potentially leading to loss of prosthetic suspension and falls.
Product
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1912-2023·2023-06-21
Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction
Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1913-2023·2023-06-21
Aspira Pleural Drainage Catheter May Fail to Drain Fluid
Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2023·2023-06-21
Aspira Drainage Catheter Tray Recalled for Potential Valve Malfunction
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction
Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2023·2023-06-21
Medicine Dropper Recalled for Potential Glass Particulate Contamination
Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.
Product
Medicine Dropper, Product Code K508
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2023·2023-06-21
Eye and Ear Dropper Recalled for Potential Glass Particulate Contamination
Apothecary Products is recalling Eye and Ear Droppers (Product Code 67082) due to the potential for glass particulate on the dropper bulb's external surface. Consumers should stop using affected units immediately.
Product
Eye and Ear Dropper, Product Code 67082
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1921-2023·2023-06-21
Exeter V40 Trial Head 26mm -3 Color Mislabeling
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
Product
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1920-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray valve assembly may fail to open
Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2023·2023-06-21
Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction
Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2023·2023-06-21
Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2023·2023-06-21
SteriPack Sterile Polyester Spun Swabs recalled due to breakage risk
LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.
Product
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1973-2023·2023-06-21
Total Knee Pack Medical Kits Recalled for Incorrect Expiration Date
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
Product
Total Knee Pack, REF CETJ130, medical convenience kits
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1907-2023·2023-06-21
Cardiosave Hybrid IABP Recall: Incorrect Compliance Annotation in Instructions
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1650-2023·2023-06-14
Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris
Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.
Product
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1666-2023·2023-06-14
StealthStation Cranial Software displays inaccurate navigation during brain surgery
A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.
Product
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1649-2023·2023-06-14
Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
Product
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1630-2023·2023-06-14
StealthStation Cranial Software Depth Gauge Synchronization Failure Risk
A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.
Product
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1651-2023·2023-06-14
Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation
Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.
Product
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1633-2023·2023-06-14
FDA Recalls Walnut Wearable Smart Thermometer Due to Reported Skin Burns
BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.
Product
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1652-2023·2023-06-14
Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected
The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.
Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1692-2023·2023-06-14
Surgical Procedure Packs Recalled Due to Included Light Handle Covers
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
Product
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2023·2023-06-14
Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results
BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.
Product
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1686-2023·2023-06-14
SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter
Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.
Product
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2023·2023-06-14
TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Category
Medical Device
Distribution
Distributed nationwide

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9276–9300 of 13731