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

33326–33350 of 40325

HighFDA (Devices)·Z-1273-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2015·2015-03-25
Mindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings
Mindray is recalling 519 Passport V Monitors because the invasive blood pressure function may provide incorrect measurements.
Product
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1272-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1274-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2015·2015-03-25
GE Healthcare Ventilators Recalled for Caster Mounting Hardware Failure Risk
GE Healthcare is recalling specific ventilator models due to a potential failure of the caster mounting hardware that could cause the device to fall or tip over.
Product
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2015·2015-03-25
Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects
Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.
Product
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2015·2015-03-25
Puritan Absorbent Foam Tipped Applicator Recall Due to Shaft Breakage
Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.
Product
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1279-2015·2015-03-25
GE Healthcare Recalls Nuclear Medicine Systems Due to Collimator Detachment Risk
GE Healthcare is recalling 472 nuclear medicine systems worldwide because a collimator may fall off during rotation. No injuries have been reported.
Product
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2015·2015-03-25
Transonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements
Transonic Systems Inc is recalling Hemodialysis Monitors that may display zero or low flow values, preventing accurate measurements during dialysis.
Product
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2015·2015-03-25
Fisher Brand Infant Heel Warmers Recalled for Burn Risk
CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.
Product
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2015·2015-03-25
Baxter HomeChoice Pro APD System Recalled for Occluder Defect
Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.
Product
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2015·2015-03-25
Smiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk
Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.
Product
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1297-2015·2015-03-25
Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives
Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.
Product
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1301-2015·2015-03-25
CooperSurgical Recalls NovaPlus Infant Heel Warmers Due to Burn Risk
CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause minor burns.
Product
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1293-2015·2015-03-25
Radiometer Crea A and B Membranes Recalled for Negative QC Drift
Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.
Product
Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and…
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-1275-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1287-2015·2015-03-25
Materialise Recalls Signature TKA Surgical Guides Due to Incorrect Patient Images
Materialise N.V. is recalling Signature TKA GDE/MDL Set 04-05 surgical guides because images from a different patient were used for production.
Product
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1296-2015·2015-03-25
Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly
Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.
Product
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1268-2015·2015-03-25
Med-logics Recalls ML 7090 Calibrated LASIK Blades Due to Fit Issues
Med-logics Inc is recalling 360 units of ML 7090 Calibrated LASIK Blades because they do not fit into the AMO Amadeus Metal Blade Holder.
Product
ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1277-2015·2015-03-25
US Infusion Recalls Medstream IV Sets Due to Leaking
US Infusion is recalling 62,700 Medstream IV infusion sets because they may leak at the Y site. The sets were distributed in six states.
Product
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1284-2015·2015-03-25
St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update
St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.
Product
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1291-2015·2015-03-25
Sybron Recalls Pinnacle Cure Sleeves Due to Mislabeling and Cross-Contamination Risk
Sybron Dental Specialties is recalling 172 units of Pinnacle Cure Sleeves because inner packaging is mislabeled, creating a risk of cross-contamination if the sleeves tear.
Product
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1289-2015·2015-03-25
Siemens N Latex IgM Reagent Recalled for Proficiency Testing Failures
Siemens Healthcare Diagnostics is recalling specific lots of N Latex IgM reagents because they failed proficiency testing, resulting in low recovery rates for serum samples.
Product
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the…
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-1294-2015·2015-03-25
LeMaitre Vascular TCI System Recalled for Incorrect Expiration Date Labeling
LeMaitre Vascular is recalling 54 units of the Tumescent Catheter Inversion System because they were mislabeled with an incorrect expiration date.
Product
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
Category
Medical Device
Distribution
7 states

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