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 deaths or serious injuries are reported, 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

9776–9800 of 13717

ModerateFDA (Devices)·Z-1215-2023·2023-03-15
epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy
Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.
Product
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2023·2023-03-15
Dental anaerobic glue recalled for incorrect expiration date labeling
Preat Corp is recalling 652 units of PREAT NOBIL GRIP dental adhesive due to incorrect expiration dates on product labels. Consumers should verify lot numbers and contact the manufacturer.
Product
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1142-2023·2023-03-08
Life2000 Ventilator poses oxygen desaturation risk with oxygen concentrators
The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.
Product
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1139-2023·2023-03-08
Life2000 Ventilator System Recall: Risk of Patient Desaturation
Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.
Product
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1141-2023·2023-03-08
Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk
Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.
Product
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1140-2023·2023-03-08
Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk
Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.
Product
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1177-2023·2023-03-08
Surgidac Uncoated Braided Polyester sutures recalled due to sterile barrier breach
Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.
Product
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2023·2023-03-08
CustomEyes kits recalled due to potential sterility compromise
Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.
Product
CustomEyes kits
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-1179-2023·2023-03-08
Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1192-2023·2023-03-08
Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management
Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.
Product
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1198-2023·2023-03-08
CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.
Product
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1171-2023·2023-03-08
Summit Medical Nasal Septal Button Recall: Unsealed Sterile Pouches
Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.
Product
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1188-2023·2023-03-08
Maquet CARDIOHELP System extracorporeal support device components recalled for sterility
Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2023·2023-03-08
EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling
Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.
Product
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, S
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1169-2023·2023-03-08
Orthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging
Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1173-2023·2023-03-08
Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.
Product
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2023·2023-03-08
Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk
Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.
Product
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2023·2023-03-08
Vascular diagnostic device recalled for air line misconnection risk
Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.
Product
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2023·2023-03-08
Med-Riser MR600 Patient Lift Boom Pivot Failure Risk Recall
Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift due to risk that the boom pivot may fail if the securing nut loosens and the bolt becomes unsecured. Contact the manufacturer for instructions.
Product
Med-Riser MR600 Patient Lift
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1170-2023·2023-03-08
Bone fixation plates recalled due to product packaging mix-up
Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2023·2023-03-08
Stryker Hoffmann LRF Transport Strut Locking Mechanism Recall
Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.
Product
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2023·2023-03-08
Surgical Mesh Recalled Due to Incorrect Collagen Film Placement
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
Product
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1199-2023·2023-03-08
Ultracell Wick with Collection Bag Recalled for Compromised Packaging Sterility
Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.
Product
Ultracell Wick with 80cc Collection Bag, 20/box
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-1206-2023·2023-03-08
X-ray System Overhead Crane May Continue Moving Unexpectedly
Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.
Product
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2023·2023-03-08
Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement
Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide

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9776–9800 of 13717