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

17026–17050 of 40248

ModerateFDA (Devices)·Z-2427-2020·2020-07-01
Argon Medical Devices Recalls BioPince Biopsy Instruments Due to Labeling Error
Argon Medical Devices is recalling BioPince Full Core Biopsy Instruments because of incorrect product labeling. The recall affects 165 units in the U.S. and 330 units internationally.
Product
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2020·2020-07-01
Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2420-2020·2020-07-01
Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues
Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2421-2020·2020-07-01
Coltene Recalls Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2426-2020·2020-07-01
RayStation Software Recalled for Treatment Record Import and Display Issues
RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.
Product
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2432-2020·2020-07-01
Siemens RP500e Handheld Barcode Scanner Recalled for Data Integrity Failure
Siemens Healthcare Diagnostics Inc. is recalling 436 RP500e Handheld Barcode Scanners because they fail to verify Code 39 barcode data integrity using check-digits.
Product
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2407-2020·2020-07-01
Utak Trace Elements Serum Control Recalled for Incorrect Reference Values
Utak Laboratories is recalling 1,395 vials of NR Trace Elements Serum Control due to incorrect cadmium reference values and expected ranges.
Product
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2235-2020·2020-06-24
GE Healthcare Recalls Giraffe OmniBed Incubators Due to Oxygen Display Error
GE Healthcare is recalling Giraffe OmniBed infant incubators equipped with Servo Oxygen modules because they may deliver a different oxygen level than displayed.
Product
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2393-2020·2020-06-24
Defibtech Recalls 860 Lifeline PRO AEDs Due to Shock Delivery Failure
Defibtech is recalling 860 Lifeline PRO AEDs because a component issue may cause the device to abort or fail to deliver a shock.
Product
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2020·2020-06-24
GE Healthcare Recalls Giraffe Incubators with Servo Oxygen Module
GE Healthcare is recalling Giraffe Incubators with Servo Oxygen modules because they may deliver different oxygen levels than displayed.
Product
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2020·2020-06-24
Medtronic Bone Void Filler Recalled for Potential Setting Defects
Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.
Product
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2388-2020·2020-06-24
Siemens MAMMOMAT Revelation Mammography System Recalled for Biopsy Removal Limitation
Siemens is recalling MAMMOMAT Revelation mammography systems because a software limitation may make it difficult to remove the vacuum biopsy system if an exam is interrupted.
Product
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2382-2020·2020-06-24
Stryker Locking Screw Recall Due to Potential Sterility Compromise
Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2368-2020·2020-06-24
Resource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
Resource Optimization & Innovation LLC is recalling Regard SRHS GIC Port A Cath devices because holes in the packaging may compromise the sterile field.
Product
Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2383-2020·2020-06-24
Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
Stryker is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2376-2020·2020-06-24
Stryker End Cap Recall Due to Potential Sterility Compromise
Stryker GmbH is recalling specific End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2374-2020·2020-06-24
Stryker Compression Screw Recalled Due to Potential Sterility Compromise
Stryker GmbH is recalling specific Advanced T2 Tibia Compression Screws because the blister pack seal integrity may be compromised, meaning sterility cannot be assured.
Product
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2375-2020·2020-06-24
Stryker End Cap T2 Tibia Recalled Due to Compromised Sterility
Stryker GmbH is recalling specific lots of End Cap T2 Tibia implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2373-2020·2020-06-24
Stryker Locking Screw Recall Due to Compromised Sterility
Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.
Product
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2020·2020-06-24
Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2378-2020·2020-06-24
Stryker Humerus End Cap Recalled for Potential Sterility Compromise
Stryker GmbH is recalling specific T2 Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2401-2020·2020-06-24
Abbott Alinity C Processing Module Recalled for Incorrect Patient Results
Abbott is recalling 421 Alinity C Processing Modules because they may generate incorrect results for specific chemistry assays.
Product
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-2386-2020·2020-06-24
Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2020·2020-06-24
AngioDynamics PICC Kits Recalled Due to Defective BD Saline Flush Syringes
AngioDynamics is recalling BioFlo and Xcela PICC Convenience Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.
Product
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2392-2020·2020-06-24
Defibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure
Defibtech is recalling 860 DDU-2300 AEDs because a component issue may cause the device to abort or fail to deliver a shock.
Product
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201…
Category
Medical Device
Distribution
Distributed nationwide

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17026–17050 of 40248