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

1426–1450 of 39824

HighFDA (Devices)·Z-1697-2026·2026-04-08
da Vinci double fenestrated grasper recalled over broken grip cables
Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Product
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including bl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2026·2026-04-08
Paradigm insulin pump delivery varies with pump height changes
Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Product
Paradigm Insulin Pump (MMT-712, MMT-715)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2026·2026-04-08
Civco eTRAX 14G needle sensor may misreport needle tip position
Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Product
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1681-2026·2026-04-08
CPX 4 SILTEX low height expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2026·2026-04-08
Medline ENFit G-tube connector kits may leak from dimensional defect
Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.
Product
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2026·2026-04-08
Medline ENFit G-tube connectors may leak from dimensional specification failure
Medline is recalling ENFit G-tube connectors because they were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices.
Product
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2026·2026-04-08
Atellica hemoglobin A1c assay may return depressed patient results
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2026·2026-04-08
Philips Azurion 3 M12 X-ray may not start from foot switch
Philips is recalling the Azurion 3 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Product
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1658-2026·2026-04-08
BD Kiestra ReadA modules may be unreachable after a system reboot
BD is recalling the Kiestra ReadA because after a system reboot one or more modules may become unreachable via the remote connectivity interface, delaying plate retrieval.
Product
BD Kiestra" ReadA; Catalog No.: 446948.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-1578-2026·2026-04-01
DuraMax hemodialysis catheter sheath introducer may not split as intended
Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Product
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1566-2026·2026-04-01
Erbe flexible cryoprobe 20402-401 recalled as Class I over rupture
Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Product
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1617-2026·2026-04-01
Trilogy Evo Universal ventilator recalled as Class I over tidal volume
Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Product
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1614-2026·2026-04-01
Trilogy Evo ventilator recalled as Class I over tidal volume
Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Product
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1616-2026·2026-04-01
Trilogy EV300 ventilator recalled as Class I over tidal volume
Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Product
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1615-2026·2026-04-01
Trilogy Evo O2 ventilator recalled as Class I over tidal volume
Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Product
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1577-2026·2026-04-01
Merit 16F splittable sheath introducer recalled as Class I bulk product
Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.
Product
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1568-2026·2026-04-01
Erbe flexible cryoprobe 20402-411 recalled as Class I over rupture
Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1576-2026·2026-04-01
ProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect
Merit Medical is recalling ProGuide Chronic Dialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Product
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1579-2026·2026-04-01
BioFlo DuraMax catheters recalled as Class I over sheath introducer defect
Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Product
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1567-2026·2026-04-01
Erbe flexible cryoprobe 20402-410 recalled as Class I over rupture
Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Product
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1588-2026·2026-04-01
Heating pad recalled as Class I because folding causes excessive temperatures
Navajo Manufacturing is recalling the Handy Solutions Neck & Shoulders Heating Pad because folding it during use raises power density in the folded area, causing excessive temperatures the limit device cannot sense.
Product
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1575-2026·2026-04-01
CentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect
Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Product
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2026·2026-04-01
I.T.S. distal humeral plates heat more in MRI than stated
I.T.S. GmbH is recalling Distal Humeral Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
Product
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2026·2026-04-01
Tandem insulin pump Czech guide inverted a key connection instruction
Tandem Diabetes Care is recalling insulin pumps distributed in the Czech Republic and Slovakia because the Czech user guide contains translation errors, including one that inverts an infusion set instruction.
Product
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1635-2026·2026-04-01
Medtronic MiniMed 780G software defects may cause insulin delivery inaccuracies
Medtronic is recalling MiniMed 780G insulin pumps on software 6.60 and 6.61 because three software defects could result in hypoglycemia or hyperglycemia through inaccurate insulin delivery.
Product
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Category
Medical Device
Distribution
Distributed nationwide

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1426–1450 of 39824