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

5526–5550 of 27375

HighFDA (Devices)·Z-1698-2024·2024-05-08
Lumbar Interbody Fusion Curette Recalled for Potential Blade Shearing
Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.
Product
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1696-2024·2024-05-08
OsmoPRO MAX Clinical Osmometer Recall for Software Errors and Result Inaccuracy
Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.
Product
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2024·2024-05-08
Abbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.
Product
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2024·2024-05-08
Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination
Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.
Product
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1723-2024·2024-05-08
ZPLP Distal Lateral Fibular Plates: locking screws may not secure
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.
Product
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2024·2024-05-08
ZPLP Distal Lateral Fibular Plates Recalled for Defective Threading
Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.
Product
ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2024·2024-05-08
Zimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.
Product
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2024·2024-05-08
Olympus POWERSEAL Surgical Sealer Recalled for Non-Functional Seal Activation
Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.
Product
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1699-2024·2024-05-08
Olympus POWERSEAL Sealer Recalled for Incomplete Seal Malfunction
Olympus Corporation is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider due to a device malfunction where the sealer fails to deliver energy upon activation, resulting in incomplete seal cycles and surgical delay.
Product
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2024·2024-05-08
Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
Product
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1742-2024·2024-05-08
Radiation therapy planning system may report overly high skin surface doses
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
Product
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2024·2024-05-08
Zimmer Fibular Plate Recall: Defective Locking Hole Threading
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.
Product
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2024·2024-05-08
RayStation Radiation Therapy Planning Software Recalled for Calculation Error
RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.
Product
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2024·2024-05-08
Unsterilized Jackson-Pratt surgical drain kits recalled by Cardinal Health
Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.
Product
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1741-2024·2024-05-08
RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.
Product
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2024·2024-05-08
Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly
RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.
Product
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1612-2024·2024-05-01
Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk
Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.
Product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1613-2024·2024-05-01
Route 92 Medical delivery catheter recalled due to tip separation risk
Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.
Product
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1614-2024·2024-05-01
Route 92 Medical Reperfusion System Recalled for Potential Device Separation
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
Product
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1464-2024·2024-05-01
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.
Product
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1610-2024·2024-05-01
Route 92 Medical Access System Recalled for Distal Tip Separation
Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.
Product
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1611-2024·2024-05-01
Route 92 Medical Reperfusion System Potential Catheter Tip Separation
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
Product
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1632-2024·2024-05-01
Hip replacement acetabular shells recalled for deburring defect
Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1631-2024·2024-05-01
Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2024·2024-05-01
Hip implant recalled for acetabular shell deburring defect
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.
Product
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Category
Medical Device
Distribution
Distributed nationwide

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