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

39376–39400 of 40449

ModerateFDA (Devices)·Z-0398-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices to update surgical instructions regarding the visual location of displaced heads.
Product
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0400-2013·2012-11-28
Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0312-2013·2012-11-28
BioMerieux BTA3D Combo Software Recall for Patient Mislabeling
BioMerieux is recalling 205 BTA3D Combo software kits worldwide due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 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-0418-2013·2012-11-28
King Systems Recalls Infant Silicone Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.
Product
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0379-2013·2012-11-28
Microgenics Recalls Thermo Scientific Omni IMMUNE Immunoassay Controls Due to Stability Issues
Microgenics is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO controls because internal testing showed reduced stability for CK-MS and Insulin.
Product
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0305-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 250 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 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 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-0399-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0200-2013·2012-11-28
GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue
GE Healthcare is recalling Brivo XR 285 and Optima XR series mobile radiographic systems due to a firmware issue affecting technique accuracy.
Product
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0330-2013·2012-11-28
GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues
Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.
Product
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0432-2013·2012-11-28
OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments
OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.
Product
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0335-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation to verify quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0303-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 860 units of 3D B.40 software updates due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 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-0336-2013·2012-11-28
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, 2x2 Pledget, 1.5%, Part# 9105-00. 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-0395-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS Slotted Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0390-2013·2012-11-28
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
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0384-2013·2012-11-28
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***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". 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-0309-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 620 units of 3D B.40 software updates because a software error may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0318-2013·2012-11-28
BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling
BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux BacT/ALERT Control Module, catalog number 210148, 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…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0415-2013·2012-11-28
Biomet Recalls Acetabular Shells Due to Label Color Code Conflict
Biomet, Inc. is recalling 16 Ranawat/Burnstein Acetabular Shells because the label color code conflicts with the liner size.
Product
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0322-2013·2012-11-28
BioMérieux 3D IND Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 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
ModerateFDA (Devices)·Z-0420-2013·2012-11-28
King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 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 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0308-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 671 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 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 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-0389-2013·2012-11-28
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
Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0311-2013·2012-11-28
BioMérieux Software Update Recalled for Patient Information Mislabeling
BioMérieux is recalling 205 software update kits for clinical instruments due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0331-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. 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

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39376–39400 of 40449