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 13731

HighFDA (Devices)·Z-1231-2023·2023-03-15
Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy
Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2023·2023-03-15
TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1211-2023·2023-03-15
Sprint 200 Wheeled Stretcher Siderail Labeling Update to Prevent Falls
FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.
Product
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1216-2023·2023-03-15
LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying
Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.
Product
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2023·2023-03-15
Cardiosave Rescue IABP Helium Regulator Failures May Impair Function
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
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
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-1227-2023·2023-03-15
BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.
Product
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodo
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
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-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-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
HighFDA (Devices)·Z-1194-2023·2023-03-08
Vascular diagnostic devices recalled due to air embolism misconnection risk
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
Product
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2023·2023-03-08
Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates
Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.
Product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
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
HighFDA (Devices)·Z-1172-2023·2023-03-08
Dermalon Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.
Product
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2023·2023-03-08
Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach
Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.
Product
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1176-2023·2023-03-08
Sofsilk Coated Braided Silk Sutures recalled for sterile barrier breach
Covidien is recalling Sofsilk Coated Braided Silk Sutures due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss during ophthalmic procedures involving direct patient contact.
Product
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2023·2023-03-08
Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements
SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.
Product
Phoenix mKDR, digital mobile diagnostic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1208-2023·2023-03-08
Dental Handpieces Recalled Due to Detachable Screw Component Risk
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.
Product
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2023·2023-03-08
Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2023·2023-03-08
Contact Lenses Recalled for Misaligned Axis Causing Poor Vision
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.
Product
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2023·2023-03-08
Surgipro II Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.
Product
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1203-2023·2023-03-08
FDA Recalls Mobile X-Ray System for Erratic Movement Risk
SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.
Product
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1195-2023·2023-03-08
Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection
Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.
Product
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Category
Medical Device
Distribution
Distributed nationwide

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9776–9800 of 13731