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

36701–36725 of 40449

ModerateFDA (Devices)·Z-0765-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation and directions for use were unclear.
Product
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0766-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0767-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0769-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0712-2014·2014-01-22
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall
Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.
Product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0757-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device validation.
Product
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0732-2014·2014-01-22
Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias
Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.
Product
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0716-2014·2014-01-22
Biomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error
Biomet is recalling 52 locking cortical screws because a 3.5mmx28mm screw was incorrectly labeled as a 3.5mmx38mm screw.
Product
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0744-2014·2014-01-22
Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors
Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.
Product
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0763-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0761-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0713-2014·2014-01-22
Radiometer pO2 Membrane Units Recalled Due to Incorrect Inner Solution
Radiometer America is recalling pO2 D999 membrane units because they were produced with the wrong inner solution, causing calibration failures.
Product
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0775-2014·2014-01-22
Lab Vision Estrogen Receptor Antibody Recalled for Performance Issues
Lab Vision Corporation is recalling Estrogen Receptor AB-11 antibody because in-house testing showed no staining on breast cancer tissues.
Product
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0773-2014·2014-01-22
GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors
GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.
Product
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0759-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0746-2014·2014-01-22
Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors
Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.
Product
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0750-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0754-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0755-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.
Product
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0745-2014·2014-01-22
Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odor Reports
Advanced Sterilization Products is recalling STERRAD 50, NX, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.
Product
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0749-2014·2014-01-22
Anspach Micro Curved Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling Micro Curved Attachment Cutting Burrs because the indications for use were broader than validated and directions were unclear.
Product
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0752-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0760-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0751-2014·2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2014·2014-01-22
Zimmer Recalls Palacos R+G Bone Cement Due to Labeling Error
Zimmer, Inc. is recalling 1,534 units of Palacos R+G Radioplaque Bone Cement because the lot number on the patient label may not match the outer carton.
Product
Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for…
Category
Medical Device
Distribution
Distributed nationwide

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36701–36725 of 40449