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 the agency’s own highest classification or reported deaths or serious injuries, 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

15726–15750 of 27471

HighFDA (Devices)·Z-1696-2019·2019-06-12
Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk
Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.
Product
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1714-2019·2019-06-12
Flowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns
Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.
Product
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2019·2019-06-12
Stryker High Flow Tube Set Recalled for Leaking and Detachment
Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Product
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1232-2019·2019-06-12
OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub.
Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1708-2019·2019-06-12
Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior
Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.
Product
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2019·2019-06-12
Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk
Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.
Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1694-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.
Product
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1697-2019·2019-06-12
Accuray CyberKnife VSI Robotic Radiosurgery Systems Recalled for Collimator Housing Drop
Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.
Product
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1728-2019·2019-06-12
Stryker Heated Tube Set Recall for Leaking and Detachment Issues
Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Product
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk
AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1698-2019·2019-06-12
Microline TLS2 Thermal Ligating Shears Recalled for Actuation Failure
Microline Surgical is recalling 115 TLS2 Thermal Ligating Shears because they fail to actuate, preventing them from performing their intended surgical function.
Product
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1719-2019·2019-06-12
Centurion Medical Recalls Sterile Nail Clippers Due to Compromised Seals
Centurion Medical Products Corporation is recalling sterile nail clippers because the sterile barrier pouch seals are compromised, potentially affecting sterility.
Product
Sterile Nail Clipper Concave Edge (67710)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2019·2019-06-12
Cook Inc. Recalls Pericardiocentesis Catheter Sets Due to Small Distal Hole
Cook Inc. is recalling 83 Pericardiocentesis Catheter Sets because the catheter distal end hole may be too small.
Product
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1736-2019·2019-06-12
Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk
Zimmer Biomet is recalling 41 Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used in the screw component, which could lead to corrosion.
Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1724-2019·2019-06-12
Cook Inc. Recalls Pericardiocentesis Catheter Trays Due to Small Distal Hole
Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.
Product
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1713-2019·2019-06-12
Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.
Product
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2019·2019-06-12
Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Material Error
Zimmer Biomet is recalling 11 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.
Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1703-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1573-2019·2019-06-05
Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Product
Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1519-2019·2019-06-05
Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
Product
Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1526-2019·2019-06-05
Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1537-2019·2019-06-05
Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1547-2019·2019-06-05
Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 38900 ECC Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1511-2019·2019-06-05
Maquet Getinge-BEQ-TOP Circulatory Circuits Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
Category
Medical Device
Distribution
Distributed nationwide

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