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

19576–19600 of 40287

HighFDA (Devices)·Z-2757-2019·2019-10-09
Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang
Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.
Product
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0033-2020·2019-10-09
Quality Electrodynamics Recalls MRI Extremity Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling five Siemens MRI extremity coils because unintended ferrous material may be present in the pushbutton assembly.
Product
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2767-2019·2019-10-09
WOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error
WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.
Product
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2758-2019·2019-10-09
Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang
Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.
Product
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0030-2020·2019-10-09
Baxter Integrated APD Set Recalled for Potential Cassette Leaks
Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.
Product
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0008-2020·2019-10-09
Baxter ExactaMix IV Bags Recalled for Potential Leaking
The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.
Product
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0035-2020·2019-10-09
Quality Electrodynamics Recalls 15CH Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling five Siemens 15CH Knee Coils because unintended ferrous material may be present in the pushbutton assembly.
Product
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0006-2020·2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed in the US and Canada.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0007-2020·2019-10-09
FDA Recalls ExactaMix IV Bags Due to Potential Leaking
The FDA is recalling 175,392 ExactaMix IV bags due to a potential for leaking. The bags are used for intravenous admixture programs.
Product
ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2761-2019·2019-10-09
Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Export
Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative results.
Product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0003-2020·2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 1,512 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0031-2020·2019-10-09
Quality Electrodynamics Recalls Two Siemens Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling two Siemens knee coils because unintended ferrous material may be present in the pushbutton assembly.
Product
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0002-2020·2019-10-09
Metrix Secure EVA Dual Chamber Container Recall for Leaking
The Metrix Company is recalling 4,284 Secure EVA dual chamber containers due to a potential for leaking. The affected bags are used for intravenous admixtures.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2020·2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking
The Metrix Company is recalling 234,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0034-2020·2019-10-09
Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.
Product
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0017-2020·2019-10-09
Inter-Med Recalls Chlor-XTRA Syringes Due to Bung Degradation Risk
Inter-Med Llc is recalling specific lots of Chlor-XTRA prefilled syringes because the rubber bung may degrade when exposed to the bleach solution.
Product
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0018-2020·2019-10-09
Implant Direct Sybron Recalls Mislabeled Dental Implant Vials
Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.
Product
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0026-2020·2019-10-09
Merit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.
Product
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0016-2020·2019-10-09
Inter-Med Recalls Chlor-XTRA Dental Syringes Due to Bung Degradation
Inter-Med LLC is recalling Chlor-XTRA prefilled syringes because the bung may degrade from chemical interaction with the bleach solution.
Product
Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0011-2020·2019-10-09
Vista Dental CanalClean Endodontic Irrigation Kit Recalled for Bung Degradation
Inter-Med LLC is recalling Vista Dental CanalClean kits because the rubber bung may degrade when exposed to bleach solution.
Product
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0014-2020·2019-10-09
Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation
Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.
Product
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2766-2019·2019-10-09
Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor
Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.
Product
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2020·2019-10-09
Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation
Inter-Med Llc is recalling 1,992 units of Vista Dental Sodium Hypochlorite syringes because the rubber bung may degrade when exposed to the bleach solution.
Product
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0001-2020·2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk
The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0027-2020·2019-10-09
Merit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling
Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.
Product
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Category
Medical Device
Distribution
2 states

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19576–19600 of 40287