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

39401–39425 of 40449

ModerateFDA (Devices)·Z-0342-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0338-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Issues
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0426-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0411-2013·2012-11-28
Gyrus Acmi Recalls Contaminated Silicone Tympanostomy Tubes
Gyrus Acmi is recalling one lot of tympanostomy tubes because the silicone was contaminated with ethylene vinyl acetate copolymer.
Product
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0416-2013·2012-11-28
Zimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads
Zimmer, Inc. is recalling 95 units of the Trilogy Acetabular System Shell with Cluster Holes because they are missing polar hole threads. No injuries were reported.
Product
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0319-2013·2012-11-28
BioMerieux BacT/ALERT Combo Module Recalled for Software Miscommunication
BioMerieux is recalling 26 BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0340-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0394-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads and fit issues.
Product
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0414-2013·2012-11-28
Kerr Laser Loupes Recalled Due to Wipeable Laser Frequency Markings
Kerr Corporation is recalling 639 Laser Loupes because the ink marking the laser frequency protection may wipe off, though the devices function correctly.
Product
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0391-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0316-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 12 kits of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0421-2013·2012-11-28
King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of adult silicone King LAD devices because sterilization indicators failed to change color as expected.
Product
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0387-2013·2012-11-28
Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up
Stryker Howmedica Osteonics is recalling approximately 72 units of 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length.
Product
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0327-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0392-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.
Product
00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0408-2013·2012-11-28
Siemens Dimension Vista Theophylline Cartridge Recalled for Abnormal Reaction Errors
Siemens Healthcare Diagnostics is recalling Dimension Vista Theophylline cartridges due to 'Abnormal Reaction' errors triggered by atypical particle reagent aggregation.
Product
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0325-2013·2012-11-28
Biomerieux B.40 Software Update Recalled for Patient Mislabeling
Biomerieux Inc is recalling 22 B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0345-2013·2012-11-28
Beckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems
Beckman Coulter is recalling 1,756 UniCel Dxl 800 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.
Product
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0300-2013·2012-11-28
BioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling
BioMerieux is recalling 375 BacT/ALERT Combo Modules due to a software error that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0304-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 30 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0341-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0383-2013·2012-11-28
ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors
ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.
Product
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0317-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 69 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0299-2013·2012-11-28
bioMerieux BacT/ALERT Control Module Recalled for Patient Mislabeling
Biomerieux Inc is recalling 70 BacT/ALERT Control Modules due to a software issue that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0326-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 23 B.40 software update kits because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
Category
Medical Device
Distribution
19 states

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39401–39425 of 40449