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

36551–36575 of 40325

ModerateFDA (Devices)·Z-0811-2014·2014-01-29
Ziemer FEMTO LDV Z2, Z4, and Z6 Lasers Recalled for Monitor Overheating
Ziemer USA Inc. is recalling five FEMTO LDV femtosecond surgical lasers because a controller board defect may cause the video monitor to overheat and shut off.
Product
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0801-2014·2014-01-29
Philips CT Scanner Recall for Obscured Machine Name Label
Philips is recalling 32 CT scanners because the machine name label is obscured in TumorLOC Basic Mode, preventing users from viewing or changing the name.
Product
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0821-2014·2014-01-29
Puritan Bennett Ventilator Manual Addendum Corrected for Oxygen Sensor Life
Nellcor Puritan Bennett is correcting a labeling error in the PB840 Operator's Manual Addendum that incorrectly stated the oxygen sensor life as two years instead of one.
Product
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0714-2014·2014-01-22
Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.
Product
Draeger Infinity Acute Care System Monitoring Solution
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0726-2014·2014-01-22
Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.
Product
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0743-2014·2014-01-22
Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk
Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0723-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues
Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0737-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks
Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
Product
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2014·2014-01-22
Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
Product
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2014·2014-01-22
Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0747-2014·2014-01-22
GE Healthcare Carescape Patient Data Module Recall for Latch Failure
GE Healthcare is recalling Carescape Patient Data Modules due to a potential safety issue involving the intermittent failure of the spring-loaded mounting latch.
Product
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2014·2014-01-22
Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias
Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.
Product
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2014·2014-01-22
Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters
Boston Scientific is recalling 39 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 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0741-2014·2014-01-22
Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
Product
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2014·2014-01-22
Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling 253 Twister Plus 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0729-2014·2014-01-22
Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The recall covers 28,562 units distributed worldwide.
Product
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0772-2014·2014-01-22
Becton Dickinson Recalls BD Interlink Threaded Lock Cannula Due to Seal Defects
Becton Dickinson is recalling BD Interlink Threaded Lock Cannulas because some units may have open seals, compromising sterility.
Product
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall
Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.
Product
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0735-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.
Product
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0771-2014·2014-01-22
Teleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns
Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices are distributed nationwide.
Product
Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2014·2014-01-22
Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters
Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.
Product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2014·2014-01-22
King Systems Recalls Supraglottic Airway Kits Due to Incorrect Component
King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.
Product
King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0724-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity
Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0736-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain tubing may leak or disconnect
Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.
Product
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide

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36551–36575 of 40325