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

17726–17750 of 40124

HighFDA (Devices)·Z-1620-2020·2020-04-08
Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk
Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.
Product
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2020·2020-04-08
Stryker AXS Vecta 74 Aspiration Catheter Recall for Potential Fracture
Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.
Product
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1603-2020·2020-04-08
Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up
Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.
Product
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1637-2020·2020-04-08
Bard WavelinQ 4F EndoAVF System Recalled for Magnetic Deficiency
Bard Peripheral Vascular is recalling 150 units of the WavelinQ 4F EndoAVF System because magnetic catheters may fail to attract, potentially delaying fistula creation.
Product
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1631-2020·2020-04-08
Ra Medical Systems Recalls Pharos Excimer Laser Due to Software Error
Ra Medical Systems is recalling 10 Pharos EX-308 Excimer Laser units because a software error may prevent the device from stopping, potentially causing skin burns.
Product
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2020·2020-04-08
DeRoyal Security Cuffs Recalled for Insufficient Buckle Hold Force
DeRoyal is recalling 94 pairs of security cuffs because the buckles do not meet required mechanical hold force standards.
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1616-2020·2020-04-08
Philips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions
Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.
Product
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1605-2020·2020-04-08
Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Cannulated Screw Systems to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1636-2020·2020-04-08
Qiagen AmniSure ROM Test Recalled for Incorrect Rinse Time Labeling
Qiagen Sciences LLC is recalling AmniSure ROM Test kits because the packaging displays an incorrect rinse time of 30 seconds instead of the correct 1 minute.
Product
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1608-2020·2020-04-08
Trilliant Surgical Disco Subtalar Implant Instructions for Use Recall
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Disco Subtalar Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1630-2020·2020-04-08
Natus Olympic Brainz Monitor Recalled for Missing Functional Tests
Natus Neurology is recalling 40 Olympic Brainz Monitors because required functional tests were not performed before release, meaning the manufacturer cannot verify system functionality.
Product
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1614-2020·2020-04-08
Trilliant Surgical Small Joint Reaming System Instructions for Use Recall
Trilliant Surgical LLC is recalling Instructions for Use and Cleaning Protocols for the Small Joint Reaming System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1627-2020·2020-04-08
Conformis Recalls iTotal CR Knee Replacement System Due to Labeling Error
Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.
Product
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2020·2020-04-08
Binding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues
The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.
Product
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1623-2020·2020-04-08
Gentell Hydrogel Ag Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 53,134 units of Gentell Hydrogel Ag 2x2 gauze because the product was not properly registered with the FDA.
Product
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1607-2020·2020-04-08
Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1613-2020·2020-04-08
Trilliant Surgical Gridlock Ankle Plating System Instructions for Use Recalled
Trilliant Surgical LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Gridlock Ankle Plating System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1610-2020·2020-04-08
Trilliant Surgical Recalls Hammertoe Implant Instructions for Use
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1617-2020·2020-04-08
Haemonetics Recalls TEG Manager Software Due to Alert Display Defect
Haemonetics is recalling TEG Manager software versions 1.1.0 through 4.1.1 because a defect causes incorrect out-of-range alerts for coagulation test results.
Product
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1615-2020·2020-04-08
Biomet Shoulder Baseplate Recall Due to Incorrect Packaging Contents
Biomet is recalling 21 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates because some packages contained two baseplates and no taper adapters.
Product
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1601-2020·2020-04-08
Butterfly iQ Ultrasound System Recalled for Lack of FDA Approval
Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).
Product
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1635-2020·2020-04-08
Trilliant Surgical Recalls 8mm Hammer Toe Reaming Kits Due to Incorrect Contents
Trilliant Surgical is recalling 117 units of 8mm HTR Sterile Hammer Toe Reaming Kits because they may contain two identical reamers instead of one concave and one convex reamer.
Product
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1611-2020·2020-04-08
Trilliant Surgical 3S Hemi Toe Implant Instructions for Use Recall
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1606-2020·2020-04-08
Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Screw Systems to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-1628-2020·2020-04-08
Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error
Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.
Product
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be…
Category
Medical Device
Distribution
Distributed nationwide

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17726–17750 of 40124