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

26051–26075 of 27686

HighFDA (Devices)·Z-2135-2013·2013-09-11
Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.
Product
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2143-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling 45 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits
DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2157-2013·2013-09-11
Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy
Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.
Product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 5 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2055-2013·2013-09-04
Zimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
Zimmer, Inc. is recalling 771 units of the Trabecular Metal Reverse Shoulder Glenosphere Distractor due to potential mechanical failure if used without proper lubrication.
Product
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2067-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2097-2013·2013-09-04
Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
Product
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is…
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-2077-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2130-2013·2013-09-04
Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
Product
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall
Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.
Product
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2094-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2075-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2072-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2092-2013·2013-09-04
Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
Product
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2013·2013-09-04
GE Healthcare Recalls Patient Data Modules Due to Signal Noise
GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2064-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2074-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2068-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2061-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2080-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state

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26051–26075 of 27686