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

11026–11050 of 27470

HighFDA (Devices)·Z-2399-2021·2021-09-08
DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error
DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2387-2021·2021-09-08
Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue
Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2380-2021·2021-09-08
Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
Product
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2405-2021·2021-09-08
Discectomy Device Kit Class II recall due to sterile barrier compromise
Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.
Product
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2390-2021·2021-09-08
Norton Arm Kit surgical device recall due to sterilization failure
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
Product
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2400-2021·2021-09-08
TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2388-2021·2021-09-08
Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2379-2021·2021-09-08
Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure
Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.
Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2021·2021-09-08
TruMatch Surgical Instruments Recalled for Software Alignment Error
DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.
Product
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2398-2021·2021-09-08
Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.
Product
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2382-2021·2021-09-08
FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2395-2021·2021-09-08
Surgical instrument software error may cause limb misalignment
DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2357-2021·2021-09-08
Medical Imaging Software Bug May Cause Incorrect X-ray Exposure
Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2396-2021·2021-09-08
Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.
Product
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2378-2021·2021-09-08
Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure
Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.
Product
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2409-2021·2021-09-08
Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2394-2021·2021-09-08
CT Pin Guide Instruments Recalled for Software Imaging Alignment Error
The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2383-2021·2021-09-08
CoolSculpting Elite System Software Error May Misreport Thermal Events
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-2389-2021·2021-09-08
Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2385-2021·2021-09-08
Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.
Product
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2021·2021-09-08
Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
Product
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2401-2021·2021-09-08
Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device
Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.
Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2285-2021·2021-09-01
Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2286-2021·2021-09-01
Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide

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11026–11050 of 27470