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

29526–29550 of 40325

ModerateFDA (Devices)·Z-2279-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.
Product
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2262-2016·2016-08-03
Metrix Dual Chamber Container Fill and Transfer Sets Recalled for Accuracy Issues
The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.
Product
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2287-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
Product
AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2297-2016·2016-08-03
Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error
Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.
Product
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2299-2016·2016-08-03
Siemens Recalls Theophylline Reagent Due to Increased Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.
Product
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2298-2016·2016-08-03
Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.
Product
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2251-2016·2016-08-03
Best Theratronics Cabinet X-Ray Systems Recalled for Performance Non-Compliance
Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.
Product
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2284-2016·2016-08-03
LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling
LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.
Product
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2259-2016·2016-08-03
Metrix AUTOCOMP6 High Speed Compounder Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 323 AUTOCOMP6 High Speed Compounders because the devices cannot meet designed accuracy specifications when dispensing into bags.
Product
AUTOCOMP6 High Speed Compounder
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2289-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.
Product
AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2294-2016·2016-08-03
MicroAire Recalls Endotine Transbleph 3.5 Due to Minor Mislabeling
MicroAire is recalling 29 units of Endotine Transbleph 3.5 because the side label lists an incorrect part number.
Product
Endotine Transbleph 3.5 (CFD-080-0167)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2263-2016·2016-08-03
Metrix Dual Chamber Container Recall Due to Dispensing Accuracy Issues
The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.
Product
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2272-2016·2016-08-03
Beckman Coulter Recalls UniCel DxC Synchron Systems Due to Leaking Solution
Beckman Coulter is recalling UniCel DxC Synchron Clinical Systems because the No Foam Bottle Assembly may leak solution.
Product
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2278-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2275-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2276-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.
Product
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2277-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2288-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
Product
AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2286-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.
Product
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2285-2016·2016-08-03
LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling
LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.
Product
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2268-2016·2016-08-03
Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error
Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.
Product
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2266-2016·2016-08-03
Alere Mono Rapid Test Recalled for Incorrect Labeling Information
Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Product
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2269-2016·2016-08-03
Alere Proadvantage Mono Rapid Test Cassette Recalled for Labeling Error
Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.
Product
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2270-2016·2016-08-03
Alere San Diego Recalls Stanbio Rely Mono Rapid Test for Labeling Error
Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Product
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Category
Medical Device
Distribution
0 states

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29526–29550 of 40325