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

2101–2125 of 39987

HighFDA (Devices)·Z-0981-2026·2025-12-31
Femoral nails, 440 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2026·2025-12-31
Femoral nails, 340 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2026·2025-12-31
Femoral nails, 420 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2026·2025-12-31
Infusion software recalled over concentration limits with insufficient decimal precision
ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2026·2025-12-31
Femoral nails, 400 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2026·2025-12-31
Femoral nails, 440 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2026·2025-12-31
Neurostimulator programmer app recalled over a device reset message that persisted
Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2026·2025-12-31
Femoral nails, 320 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509320, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2026·2025-12-31
Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2026·2025-12-31
Femoral nails, 400 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2026·2025-12-31
Infusion drug library software recalled over a failing change review option
ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2026·2025-12-31
Femoral nails, 420 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2026·2025-12-31
Femoral nails, 300 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815609300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2026·2025-12-31
Dialysis concentrate 100225 recalled because safety and efficacy cannot be assured
Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0993-2026·2025-12-31
Check-Flo introducers recalled over products manufactured out of specification
Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Product
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) K
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0984-2026·2025-12-31
Campylobacter control kits recalled because they may fail to recover the organism
Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2026·2025-12-31
Campylobacter LYFO DISK controls recalled over failure to recover the organism
Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0985-2026·2025-12-31
Campylobacter six-pack control kits recalled over failure to recover the organism
Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0963-2026·2025-12-31
Cranial tracker devices recalled over an error message preventing use
Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0994-2026·2025-12-31
Transjugular access sets recalled over products manufactured out of specification
Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Product
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0995-2026·2025-12-31
Transjugular liver access sets recalled over products manufactured out of specification
Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Product
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0885-2026·2025-12-24
Infusion pump software recalled over anomalies that could cause serious harm
Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Category
Medical Device
Distribution
20 states
CriticalFDA (Devices)·Z-0914-2026·2025-12-24
Carestation 750 anesthesia systems recalled over potential unexpected shutdown
GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestatio
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0913-2026·2025-12-24
Anesthesia systems recalled over potential unexpected shutdown on mains power loss
GE Medical Systems is recalling 1,277 Carestation anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The FDA has classified the action as Class I.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0915-2026·2025-12-24
Anesthesia power management boards recalled over potential unexpected system shutdown
GE Medical Systems is recalling 203 Carestation anesthesia system Power Management Board field replaceable units over potential unexpected shutdown if AC mains power is lost.
Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Category
Medical Device
Distribution
Distributed nationwide

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2101–2125 of 39987